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Specialist - QA Ops - Manufacturing Mgmt
Salary undisclosed
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- 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
- 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)
- 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
- 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)