Manufacturing Oversight
- Supervise and monitor pharmaceutical production processes to ensure compliance with approved formulas and batch manufacturing records (BMRs).
Quality Assurance & Compliance
- Ensure compliance with national and international regulatory requirements (e.g., GMP, ISO, WHO guidelines).
- Participate in internal and external audits and implement corrective and preventive actions (CAPA).
- Review and approve standard operating procedures (SOPs).
Quality Control Collaboration
- Work closely with Quality Control to ensure raw materials, in-process products, and finished products meet required specifications.
- Review analytical results and investigate out-of-specification (OOS) results.
Batch Documentation
- Prepare, review, and approve batch production and packaging records.
- Ensure accurate and complete documentation in line with regulatory standards.
Regulatory Affairs Support
- Assist in product registration, variation submissions, and regulatory inspections.
- Ensure compliance with labeling, packaging, and regulatory approvals.