- In-Process Quality Assurance (IPQA) and manufacturing operations.
- Batch Manufacturing Record (BMR) review and documentation control.
- Quality Management Systems (QMS) and SOP compliance.
- Validation and qualification activities.
- Internal audits, regulatory inspections, and compliance.
- Implementation of cGMP and regulatory requirements (WHO/TGA). Qualifications &
Skills:
- B.
Sc. / M.
Sc. / B.
Pharm. / M.
Pharm.
- Valuable knowledge of cGMP guidelines, 21 CFR Part 210/211, and ALCOA+ data integrity principles.
- Strong documentation skills and attention to detail.