Quality Control Scientist / Subject Matter Expert

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

In this role, you are responsible for managing QC-Methods validation projects and being

A key member of Quality Control Laboratory team, this position will regularly work cross functionally with other Celgene QC, MTS, ATS, PAT, REG, CMC, QA, IT, Drug Product Development and Vendors:


Subject Matter Expert, SME, for QC-Methods Validation, laboratory Instruments & Software,data integrity and LIMS
Ensure compendia, non-compendia, and cleaning validation QC-methods are validated/verified and maintained in compliance with local policies, guidelines, and procedures during their lifecycle
Author and when required review validation documents, including QC-Method transfer, QC methods verification, validation plans, protocols, reports, summary reports
You manage & execute PQ methods validation
You participate to the development and maintenance of the local site procedures and to risk assessments / risk management teams
You are change control leader for the QC department for methods review or implementation, review and approve control documents, to evaluate impact on qualified systems and validated processes
You manage validation projects; including managing time, resources and budgets; own associated change controls
You develop and justify the validation approach based on risk and a scientific rational
You co-ordinate qualification and validation execution activities, including external vendors and internal departments
You maintain procedures governing validation to ensure they are in compliance with Corporate policies and regulatory requirements
You participate when required during internal and external audits for which they are a SME, by answering questions, reviewing Methods validations/verification with auditors, and providing documentation.
You establish and maintain effective relationships with internal team, customers and suppliers


You have:


BS degree in Chemistry
Minimum 5 years' experience in QC-methods validation;
Minimum 2 years' experience in managing QC-Methods validation projects;
Familiarity with current international regulatory regulations, cGxP requirements and best practices, including USP, Ph.Eur,, JP, 21 CFR part 11, 210 and 211, Annex 11 to EU-GMP
guidelines and GAMP;
Experience in QC-Instruments purchasing & qualification
Good kknowledge of pharmaceutical facilities and laboratory systems;
Good communication skills in English with laboratory, technical operations, QA, and outside vendor groups;
Team player: ability to interact effectively with team and customers.


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Bristol-Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees the resources to pursue their goals, both at work and in their personal lives.

Company: Bristol-Myers Squibb

Req Number: R1521544_EN

Updated: 2020-02-12 00:00:00.000 UTC

Location: Couvet,Switzerland

Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

Company info

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