Job Description

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.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)

Skills Desired Continued Learning, Dealing With Ambiguity, Gmp Procedures, Qa (Quality Assurance), Quality Control (Qc) Testing, Quality Standards, Self-Awareness, Technological Expertise, Technological Intelligence

Novartis