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
Role Requirements
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
Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
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
