Quality Assurance Manager
The profile is responsible for the management of Quality Assurance systems including managing and implementing Company procedures in accordance with relevant EC Directives, including 2001/82/EC and Annex 16 of the EU Guide to Good Manufacturing Practice. As Qualified Person (QP) is required to manage and implement Company Batch Release procedures in accordance with the relevant EC Directives including 2001/82/EC and Annex 16 of the EU Guide to Good Manufacturing Practice. Aiming at a safe place to work, the position will counsel and collaborate with the site EHS leader to support him in creating and sustaining an excellent EHS culture, and collaborate with other site functions to create and sustain an excellent site operating culture.
DUTIES AND RESPONSIBILITIES:
Management of QA Systems:
- Ensure effective monitoring of processes according to European and US directives and regulations.
- Review procedures and documents according Compliance/GMP. Ensure all SOPs and other related documents in QA follow GMP and Zoetis Quality Systems.
- Management of deviations (generation, investigation, impact, reporting and approval).
- Management of change control, deviations and complaints.
- Review of Quality Control (QC) out of specification results and investigations.
- Prepare QA SOPs related to the management of QC testing.
- Review of quality acceptance criteria for raw materials, intermediates products, API and finished products.
- Management of raw materials, packaging materials and finished goods sampling/reserving; release semi-finished goods and finished products.
- Review batch process records and QC test reports.
- Handling of returned goods, rejected goods and customer complaints.
- Annual quality review and GMP self-inspection.
- Ensure all SOPs and other related documents in QA follow GMP and Zoetis Quality Systems. Be responsible for documentation control.
- Supplier qualification (audits) in accordance with Zoetis Quality System.
- Review stability testing program, and provide data to confirm the storage period for semi-finished and finished goods.
- Review and approve validation protocols and reports
- Bachelor degree in chemical science, pharmaceuticals, or related specialty.
- Qualified Person.
- At least 5 years experience in QA within a pharmaceutical manufacturing company.
- Familiar with GMP regulations.
- Good capability of solving problem during testing and treatment for instrument failure.
- Communication skills.
- English reading and writing.
- Thorough knowledge of computer systems and software.
- Knowledge of Microsoft Office software package. The knowledge of ERP system (SAP and its LIMS module) or quality softwares Empower, Trackwise, etc. are preferential titles.
- Become familiar with GMP regulations, Zoetis Quality Systems and Company procedures, and application to the site’s pharmaceutical and medicated feed additive manufacturing process.
- Good administration capability , communication and solving problem.
- Good teamwork capability, cooperation skills, and continually improving skills.
- Strong knowledge of Environment, Health and Safety topics.
- Knowledge in Process Safety and Industrial Hygiene.