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.