Senior Specialist - QA Ops - Manufacturing Management

Summary

This role supports/provides 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 driven in alignment to site objectives.

About the Role

• Ensure all activities in compliance with cGxP, including data integrity
• Review and approval of analytical data/tests (analytical release)
• Oversight of all production and testing activities, ensuring compliance with cGxP, including data integrity and eCompliance
• Support exception investigations
• Review and approval of production, QC, and AS&T records
• MBR review. Support OpEx improvement projects. Execute batch release in compliance with registration (if Qualified Person)
• Comply with all HSE guidelines. Detect and report potential accidents, risks and propose solutions
• Participate in HSE risk assessments. Preparation and participation in internal HSE audits

Role Requirements:

• 3+ 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

• 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. Collaborating, supporting, and inspiring each other to achieve breakthroughs that change patients’ lives.