- Initiate QA SOPs and coordinate the initiation, review and approval of SOPs and documents.
- Ensure the efficient distribution and withdrawal of records, SOPs and protocols.
- Collect and archive the required documents.
- Manufacture monitoring /Review the Batch Manufacturing / Packing Records.
- Review/ approve label artwork.
- Responsible for training management, develop training plan, prepare GMP training materials.
- Ensure the cGMP compliance.
- Manage validation plan and follow up execution, review validation protocols and reports.
- Manage change control & deviation & CAPA.
- Assist QA Manager to prepare regulatory and participate vendor audit.
- Bachelor degree or above in Pharmaceutics/Chemistry or related degree
- Experience 3-5 years in quality assurance management, quality control background and expertise is a plus
- Familiar with regulations, (C)FDA cGMP/GLP, ICH guidelines and Pharmacopoeia
- Good Leadership and communication skills
- Fluent in English