65 Project Leader jobs in the Canton of Neuchâtel

Get updates by email

QC Specialist

18.02.2020 | Employee | 100%

QC Specialist

Share This Page QC Specialist Qlty Assurance Methods Couvet, , Switzerland Full time R1521544_EN 2/12/2020 4:10:34 PM 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 Life Sciences, Chemistry, Engineering or equivalent; 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. 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. Working with Us By fostering a culture of inclusion, we empower this 21st century workforce to achieve our company's mission of helping patients to prevail over serious diseases. Explore Job Opportunities A clear purpose. An inclusive culture. The chance to work at the top of your field. These are a few of the reasons Bristol-Myers Squibb is the right choice for your next career move. Come Meet Our Team Are you ready for a career where you make a profound difference? We invite you to visit us at one of our events to learn more. For US Applicants Only Bristol-Myers Squibb endeavors to make this website accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact . This contact information is for accommodation requests only and cannot be used to inquire about the status of applications. The Physician Payment Sunshine Act (Sunshine Act) requires Bristol-Myers Squibb to report any transfers of value, including payments made to reimburse interview-related expenses, for candidates who are US-licensed physicians. U.S. licensed Physicians covered by the Sunshine Act include Doctors of Medicine, Osteopathy, Dentistry, Dental Surgery, Podiatry, Optometry and Chiropractic Medicine who are licensed to practice medicine in the U.S. This information will be reported to the Centers for Medicare and Medicaid Services (CMS) on an annual basis and CMS shall post submitted data on its public database. For more information, 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. For our EEO Policy Statement, please . If you'd like more information on your EEO rights under the law, please click here: and Follow Us Powered by © 2018 Bristol-Myers Squibb Company

This website uses cookies to ensure you receive the best service. Further information can be found in our Terms and Conditions and in the Privacy Policy.