摘要
About the Role
Key Responsibilities:
- The QA Specialist will serve as QA technical subject matter expert for CSV process, such as MES, KNEAT, DCS, including but not limited to GMP enterprise systems, manufacturing systems and computerized equipment, laboratory systems and computerized equipment and validation software tools.
- The role will also provide QA oversight for MES qualification activities such as URS, IQ, OQ and any qualification activities by supporting review, and approval (as applicable) of QA records including SOPs, site deviations, CAPAs and change control records related MES project.
- Hands on experience with MES, KNEAT and DCS
- Experience with Agile, 1QEM system
- Ability to work with tight deadlines as well as strong planning, organizing and time management skills. Attention to details, dedication to accuracy
- Reliable and with high sense of accountability. Ability to work independently
- Strong problem solving and analytical skills.
- Reliable team-player with strong competence in leading cross-functional teams and operating within a matrix organizational structure.
Essential Requirements:
- Minimum of 3 to 5 years of experience in quality assurance and GMP in the pharmaceutical / biotech industry is preferred .
- Minimum Bachelor degree in a scientific discipline (e.g. pharmacy, chemistry, engineering, life science) or similar education; advanced degree in natural or applied sciences preferred
- Enhanced Computer skills
- Proficient in English Required
Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
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Benefits and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
Accessibility and accommodation
Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
