12 Dec pharmaceutical gmp resume
Function head within a Life Sciences Research organization preferrred, Minimum 10 years leadership experience managing teams; proven ability to build, manage and foster a team-oriented environment, Deep understanding in one or more of the following: pharmacology, biologics, genomics, cheminformatics, translational science, Expertise in research / laboratory processes and methods, assay workflows, data management and data curation, Experience in one or more of the following: knowledge mining, scientific data curation, target profiling, drug repositioning, Significant client impact and value creation, On time and on budget high quality project delivery, Significant experience with research informatics software and solutions, including research platforms, workflow systems, and data aggregtation, management and curations solutions in the Research / Early Discovery spaces, Experience working with executives in Life Sciences R&D, with network of existing clients, Significant responsibility leading teams and exceptional team building/ mentoring skills, Excellent leadership, client-facing communication (written and oral) and interpersonal skills, Follow-on project sales and ability to sell work to new clients, Technically savvy and/or interest in working with technology as part of identifying and delivering solutions to clients, Experience with scientific software/ knowledge management solutions, Orchestrating and bringing together expertise from across the entire organization—strategy, consulting, digital, technology and operations—to deliver value to clients, Selling the full breadth of Accenture’s services, 4+ years of experience with regulatory information management tools in a consulting, implementation or support capacity, with exposure to all phases of a regulatory information management tool implementation including requirements gathering, development, deployment and support preferred, 4+ years of experience managing a team of multiple direct reports, clients and vendors, Typically we work at client sites. Performed In-Process inspection and released filling and packaging operation Monitored and conducted GMP compliance inspections and audits of manufacturing and packaging area (including compounding, aseptic core and pharmacy areas) Provided support to quality investigations. HSE criteria, quality criteria, critical path milestones), Complete the scope of work to the satisfaction of the client and key stakeholders, while simultaneously ensuring that CH2M HILL’s HS&E, quality, financial, risk management, business and policy expectations are met, Play a role in the business development activities leading to the award of the contract. This notebook is numbered, signed out, and is part of Corporate record retention guidelines, Formalizes analytical methods to be utilized in the evaluation of raw materials, intermediate, APIs, and drug products and creates protocols and test procedures to be followed in future testing, Performs peer review of other analytical research associates’ methods, results, and documentation, Assists with instrument qualification, metrology, and maintenance, Creates, reviews, and/or revises laboratory SOPs when appropriate, Experience developing, revising executing analytical methods, Knowledge and understanding of a variety of analytical techniques including UPLC, GC, UV-Vis Spectrophotometry, and Karl Fischer titration, Experience performing qualitative and quantitative analytical tests, Minimum of 3 years analytical laboratory experience, Familiarity with cGMP regulations and FDA and ICH guidelines, Contribute to the overall evolution of SLF’s Drug Benefits strategy and the products roadmap, Present the Drug Benefits vision at client presentations and industry conferences, Develop strong relations with the various level of governments, as needed, to represent our customers best interests (e.g. Some international travel may be required, 3+ years pharmaceutical sales experience with proven track record of success, Required residence in territory geography, Knowledge of Women’s Healthcare market preferred, Demonstrated competency with studies/clinical reprints and other third-party proof sources, Proven PC skills required (Microsoft tools), Ability to read, analyze and interpret general business trade journals, professional journals, and financial reports, History of building a network of customers and industry contacts, including KOLs and speakers, Responsible for continued knowledge development and market trend analysis, Proven track record of achieving annual target goals, Ability to work independently and without direct daily supervision, Skilled in strategic selling with a desire to assist others to achieve success, Excellent verbal and written communication skills necessary, Strong presentation skills with respect to products and tertitory, Valid driver’s license to travel to customer locations, Work with the other pharmaceutical operators and supervisors in assigned area to establish priorities and meet deadlines. This includes, Developing robust formulations and manufacturing processes for all pipeline products in PTDU portfolio, Develop new technologies & innovative drug delivery approaches enabling future products, such as ocular products, co-formulated products and sustained release products, Identify, prioritize & oversee DP processing technology development efforts in line with mid to long term business objectives, Oversee execution of drug product process characterization and validation programs in preparation for licensure, with a focus on continuous improvement and productivity, Oversee equipment development and qualification activities, Provide leadership direction for production of material in Genentech’s clinical & commercial manufacturing facilities, transferring formulation & technical knowledge and processes to commercial sites and providing ongoing support where appropriate, Ensure sufficient expertise is available to support all Drug Product programs, Provide senior level contributions to the development of the PTD business strategy, culture and capability, Take personal accountability to Sponsor PTD initiatives and projects as requested by PTD leadership, Implement CMC Productivity initiatives and cultivate an organizational culture that is agile, lean, innovative and encourages smart risk taking, Provide leadership and development of staff with strong focus on continuous improvement, performance management and career development, Foster teamwork among global and local colleagues, Evidence of strong established relationships with local endocrinology specialists, Understanding of the business drivers, dynamics, regulations and market access environment within the pharmaceutical industry, Skills at building and maintaining professional relationships with key customers, office staff and others in the customer influence network, Strong business analytics to analyze data as well as develop, execute and adjust business plans, Conduct and/or oversee laboratory research in process development for pharmaceutical sterile products, Evaluate, recommend, and oversee contract research and manufacturing organizations capable of providing the technical services required, Direct and coordinate process optimization of development formulations, Direct and participate in technology transfer and validation efforts at commercial manufacturing sites, Provide technical support of commercial products to ensure adequate supply at all times, Coordinate project activities with other internal functions through the Product Development Teams, Review of CMC documentation for US and ROW submissions, Build and maintain a strong working relationship with colleagues in Analytical Research, Project Management, Quality Assurance, and Regulatory Affairs, Prepare and review CMC submission documents, Interface with Regulatory Authorities pre and post submission as required to support global filings, Participate in due diligence activities as required, Ph.D. in a relevant discipline, with ten (10) years experience in sterile pharmaceutical dosage form technology/development, or M.S. Die in der Regel hochrangigen Mitarbeiter nationaler Arzneimittelbehörden werden von Repräsentanten aus allen EU-Ländern und aus den EU-assoziierten Ländern Island, Liechtenstein und Norwegen gebildet. Shares expertise, instruments and resources within the limitation of established priorities, Maintains a good and current knowledge of the scientific and technical literature pertinent to the project and necessary for development of state of the art production and analytical methods and acquisition of reasonable and necessary equipment, Makes high quality scientific presentations at internal management, regional and national meetings to help advance Allergan’s image as the thought and product leader in the neuromodulator and eye care field. Drive creation of processes for technology landscaping and partner selection, Serve on joint Development and Steering Committees for partnered projects, Visual inspection of vialled products for pharmaceutical use; work is carried out under GMP, Carrying out visual inspection of filled vials, both freeze dried and liquid filled, using approved procedures, Remove defective products based on agreed reject categories, Reporting of each inspection in batch manufacturing records in accordance with GMP, Sampling raw materials and finished product, Control of finished product storage and storage areas, Document storage locations per batch in inventory, Ensure storage areas are monitored and perform checks as directed by supervisor, Communication with clients regarding labelling, dispatch, stock control etc, Generation of product labels as per client instructions, Labelling of product vials per agreed batch manufacturing instructions, Arranging dispatch of materials to Client/Clinic sites as appropriate, Book transportation to coincide with the size of dispatch to meet the clients delivery deadlines, Participation in training sessions in support of the above activities, Ensuring training record folders are suitably maintained with appropriate documentation to show competency for each activity performed, Participate in maintaining housekeeping standards and audit readiness of facility, Completion of batch manufacturing records, worksheets, forms and logbooks to the required standard in support of the above activities, Preparation of relevant documentation to support department activities, Communicate and help resolve any customer complaints as necessary, Participation in customer and regulatory audits/inspections as required, All other reasonable activities in support of department functions under the direction of the Logistics Supervisor or Production Managers, 3+ years pharmaceutical experience outside of retail industry, Strong ability to multitask and work in a fast paced environment, Flexible and adaptable, able to adjust to emerging product requirements, Excellent critical thinking and organizational skills, Must be able to evaluate literature and summarize findings, Must be a self-motivator and work independently and as part of a team, Ability to use knowledge as pharmacist to organize and develop drug information based on clinical needs of physician readers, Ability to prepare additional material or rewrite content, as needed and match publication style and requirements, Ability to create new drug monographs (tables) when new molecular entities approved by the FDA and enter them in database, Ability to update database with new indications, new dosage regimens, and other pertinent information (eg, precautions, warnings), Ability to verify accuracy of content in existing monographs, Ability to identify, correct, and review drug interactions, Detailed oriented, precise, and rigorous regarding the implementation of style guides, Working knowledge of Microsoft Office Suite particularly with Excel and Word, Develop clear event and strategic communications plans, Evaluate the value of effective corporate communications, both internally and externally, Learn how to navigate a complex organization and manage internal stakeholders, Currently enrolled in a 4-year bachelor undergraduate (minimum) program and pursuing a degree in Communications or related field, Excellent written and verbal communication skills; detail-oriented, Self-starter who can work on multiple priorities in a fast paced environment, Ability to work both collaboratively and independently, Ability to interact professionally with internal stakeholders at various organizational levels, Basic problem solving skills and project management abilities; resourceful, Strong computer skills with Microsoft Office proficiency (Word, Excel and PowerPoint), Manage/perform site projects focused on Process Validation, process optimization, process trouble shooting and new product introduction, Evaluate project budgets, forecast, expenditures and accomplishment of objectives and ensure all projects are executed on time and within budget, Open and close change controls for each project as necessary, Assess the effectiveness of current projects and identify possibilities for new projects and opportunities, Coordinates resources from Engineering, Quality Assurance, and production personnel assigned to specific projects, Furnish direction to engineers and technicians regarding project requirements, Develops and communicates project timelines and status, Generation and execution of protocols for both new and marketed products including the qualification of new chemical raw materials and components, Work with other departments to ensure identified work items are addressed in a timely and satisfactory manner, Perform filing, computer input/output tasks and prepare identified reports as required, Address internal and external customer queries under the guidance of the department supervisor/manager, Assure our business practices enhance the welfare of our customers, employees and community in which we operate, Ensure that all activities are fully compliant with all criteria established by governmental agencies, Ministries of Health and legislative requirements, Assist Allergan in achieving environmental, health, and safety goals by working safely and observing all general plant and department safety policies, Perform all assigned duties according to departmental SOP’s and cGMP’s, and company policies, Remain current on proper procedures by reviewing current, revised, and new SOP’s relating to the job and to the department, Complete and remain current with all required cGMP and safety training, Strong financial and cost accounting skills desired, Knowledge and understanding of current Good Manufacturing Practices (cGMP), Knowledge and understanding of Regulatory Compliance criteria established by Governmental Agencies, Boards of Health and Legislative Requirements, such as FDA, OSHA, EPA, and DEA, Basic knowledge of strategic and tactical issues in an operations environment, Ability to handle multiple projects, duties, and assignments, Ability to read, comprehend, write, and communicate effectively in English, Ability to carry out detailed written or oral instructions, Ability to work and communicate with others in a professional and effective manner, within a team-oriented environment, Knowledge and understanding of personal computer operations, including Windows-based computer systems such as Microsoft Office applications (Word, Access, Excel, PowerPoint, MS Project), with an ability to learn other computer based systems, Understanding of equipment qualification / calibration concepts, Understanding of pharmaceutical raw material tests and raw material characterization, Ability to perform intermediate statistical computations (Cp, Cpk, regression, analysis), and practical application of statistical software, Knowledge and application of process improvement for all types of products, Knowledge of process / cleaning validation processes, Ability to employ sound leadership skills for providing guidance to project teams, Ability to solve practical problems, considering a variety of concrete variables in situations where only limited standardization exists, Responsible for the development and pre-validation of analytical methods using multiple analytical techniques including HPLC, CBPA, qPCR, Western blots, UV and other general methods as needed. This will require some, Leadership and communication (verbal and written) skills and ability to be part of team, The clean room manufacturing environment requires personnel with good personal hygiene, Adaptability to change and to perform under pressure with time constraints, Bachelors Degree and a minimum 3-years supervisory experience, preferably in the pharmaceutical industry, Must have aseptic pharmaceutical experience, Experience in a manufacturing environment or advanced mechanical training is a plus, Drive corporate relationships by understanding customer life cycle and contract timeframes, Coordinates needs and opportunity assessments across locations, Measures customer satisfaction and develops strategies to improve, Identifies target profitability, terms and conditions, Coordinates and communicates business development initiatives and strategies, Creates and manages the account strategy and implementation plan, Provides direction to managers/sales representatives on expectations for the servicing account, Drive market share improvement and identify standard marketing programs/promotions relevant to customer, Evaluate customer performance for contract compliance, 10+ years of relevant work experience; strong background in science and the specific industry segment, Demonstrated ability to maintain and grow senior level customer relationships across multiple areas like Sourcing, Production, Research, Materials Management, Strong financial analysis, negotiation, and project management skills, Strong leadership skills in a matrix environment, Identify, qualify and develop new opportunities with current and new customers, based on Siemens Portfolio, Develop and maintain knowledge of competitive products and create sales support materials to promote Siemens products vs. the competition, Provide sales assistance and knowledge of the Siemens technology, Create and deliver presentations to customers during sales visits, Gather and communicate input from field to marketing regarding market trends, customer satisfaction, competition, product issues, Work closely with the Market Development team in executing strategies needed to meet the business objectives, Support local sales management in presenting the technology to potential new customers, Develops and communicates a clear strategy for the area/market and achieves business commitment and support, Position Siemens as a key partner to customers and enables top level strategic discussions, Creation of opportunity “Win strategies”, defining customer spend strategy, competitive environment and identifying business development requirements, Develops and presents technical proposals, including Value Proposals, Guides customers to develop investment plans that are feasible within cost, time, and environment constraints, High availability for travel constantly achieving a high productivity, Discipline and organization to achieve a time balance of 75% in activities with customer and 25% in office activities, Discipline and organization for use above 70 per cent of working time in activities against and for the customer, reaching a high productivity, Abide by all business compliance requirements in line with Company policies, Develops strong personal relationships with the customer and leverages this to achieve better sales and business results, Delivery excellent customer service & monitor customer satisfaction levels, Able to spot previously unidentified business opportunities, Frames and communicates strategic opportunities into the business, Energized by creating better ways of doing things, so that higher levels of sales performance can be achieved, Wide knowledegement of the Pharma industry, Wide knowledgement of the service portfolio, Prior experience with electrical equipment, Communicates staffing needs on shift to Account Manager or Operations Manager, Assures that officers receive appropriate training, developing them in both technical and professional skills; also may. This includes authoring / reviewing protocols and reports as well as evaluating the results and leading technical discussions with project team members and external contractors, Ensure all cGMP data generated for development projects are managed and evaluated as described in relevant internal procedures and regulatory requirements, Quickly and effectively resolve complex analytical issues and deviations / investigations, Effectively communicate complex technical issues and deliver concise presentations to management and non-technical stakeholders, Actively contribute to the preparation and coordination of internal audits and regulatory inspections, Provide technical input for selecting external Shire contractors and manage day-to-day contractor activities for respective projects, Create and enhance collaborative and trusting relationships internally and with personnel at Contract Research Organizations (CROs), Serve as a peer-leader to motivate / inspire colleagues and to mentor others in various aspects of analytical and problem-solving methodologies, Maintain a high level of professional and technical expertise through familiarity with scientific literature, conference attendance, and participation in training courses, Author and/or review relevant API and drug product CMC sections for global regulatory submissions (IND/CTA and NDA/MAA and annual reports) and ensure sections meet submission ready standards regarding content and format, Assist with responses to regulatory agencies regarding stability and analytical-related inquiries, Maintain awareness of current trends regarding global regulatory CMC requirements through literature and conference attendance, Ensure analytical test methods, development reports, and specifications are compliant with internal procedures and regulatory requirements, Assist in the development and implementation of departmental processes, procedures and policies, Maintain adherence to departmental and quality systems, such as SOP training records, deviations/investigations, CAPAs, and Change Controls, Supervise / coach less experienced staff as needed, Requires an advanced degree (MS or PhD) in Chemistry, Chemical Engineering, Pharmacy or closely related field and at least 8 years of relevant analytical experience within the Pharmaceutical Industry, Direct experience with the analytical support of synthetic peptides or oligonucleotides, Experience with analytical support of sterile products, Strong knowledge of ICH and other regulatory guidelines, Knowledge and experience with product development and clinical supplies processes, Knowledge and experience with statistical applications for data evaluation, Experience in authoring analytical-related CMC sections of IND/IMPD and NDA/MAA regulatory submissions, Experience working with Contract Research Laboratories, Proven experience with various quality systems (e.g. Supports vendor contracted to manufacture standards as appropriate, Performs qualitative and quantitative analytical tests utilizing approved protocols and test procedures in support of the Stability Testing Program for APIs and drug products, Documents laboratory activities and maintains laboratory notebook. Seek end user insights to create new ideas/products for specific segment requirements with PLT teams, Relationships: Establish and maintain in close co-operation with LPM Asia Pacific, a successful long term product strategy to achieve required sales value and margins along with the objectives (manage product life cycle), Product Portfolio & Inventory: Manage the regional product portfolio to ensure that the right inventory and/or products are manufactured or kept at the distribution centers & plants, Measurement and Analysis: Assess current revenue performance and monitor product profitability. It is of crucial importance for us to follow the international law regulations and standards of Good Manufacturing Practice (GMP) in order to develop high-quality medicines which will ensure a […] Provide technical leadership skill in all activities related to the development of the assigned engineering projects, Industrial experience preferably 10+ years, Successfully demonstrated several years (mini-mum of 3 years) of directly related experience (within relevant industrial setting), Meet quality, quantity and timelines in all assigned projects, Plan, organize, perform and document scientific experiments/plant activities in collaboration with experienced team members if necessary. Every company that manufactures drugs has a responsibility to implement these controls throughout the manufacturing process, from sourcing raw materials to production and distribution. - Choose from 15 Leading Templates. Uses the personal protective equipment (PPE) required for the process or task to be performed. Good Manufacturing Practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. D/Master’s degree OR Bachelor's degree preferably in a health-related, scientific or engineering field with a minimum of 3 years of work experience in the pharmaceutical industry, drug development, and/or project management, Previous experience with or knowledge of drug development processes, Higher degrees or certifications (e.g. Depending on your location and specific project responsibilities, this position may require up to75% travel (Monday – Thursday), Proven ability to build, manage and foster a team-oriented environment, Desire to work in an information systems environment, Excellent communication (written and oral) and interpersonal skills, Excellent leadership and management skills, Understanding of key Pharmaceutical R&D processes andtechnologies. Acts as an advisor to subordinate(s) to meet schedules and/or resolve technical problems. 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