Job Posting for Specialist - QA Ops - Manufacturing Management at Novartis
Summary
This role support/provide quality oversight in ensuring a smooth manufacturing operation, new product launches/transfer in a compliant/timely manner, drug substance batch review/release are in full gmp compliance to regulatory standards and ensures quality strategy/continuous improvement are executed in alignment to site objective/s.
About the Role
Key Responsibilities:
Ensure all activities in compliance with cGxP, incl. data integrity
Review and approval of analytical data / tests (analytical release)
Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
Support exception investigations
Review and approval of production, QC, and AS & T records
MBR review. Support OpEx improvement projects. Executes batch release in compliance with registration (if Qualified Person)
Comply with all HSE guidelines. Detect and report potential accident, risks and propose solutions
Participate in HSE risk assessments. Preparation and participation to internal HSE audits
Role Requirements :
Essential Requirements:
5 years of experience in pharmaceutical quality control, quality assurance or production
Operations Management and Execution; Functional Breadth; Collaborating across boundaries; Applied Practice
Collaboration; result-oriented. Good knowledge of GMP; Continuous Learning; Operational Excellence; Digital & Tech Savvy
MS Office applications and other standard IT applications supporting Quality activities
Technological competence; Quality Assurance; Knowledge of GMP, Quality Standards; Quality Control (QC) Testing
Desirable Requirements:
University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)
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
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.
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