GMP Cordinator

Responsibilities:

• Monitor manufacturing processes and the plant environment to ensure compliance with GMP requirements and approved SOPs.
• Coordinate the calibration of balances and measuring devices across the plant.
• Verify manufacturing orders and coordinate sampling of intermediates for quality evaluation.
• Coordinate product stability studies and temperature mapping activities.
• Manage the issuance, retrieval, control, and archiving of GMP-related documents.
• Prepare and coordinate Product Quality Reviews (PQRs) and other quality reports.
• Ensure the use of approved and current documentation for manufacturing, packaging, and testing activities.
• Participate in internal quality, housekeeping and regulatory audits.
• Conduct GMP, GLP and laboratory safety training for relevant employees.
• Participate in the assessment of returned goods, product recalls and imported products.
• Support other Quality Assurance activities and deputize for the Quality Assurance Manager when required.

Requirements:

• Minimum of 3 years' relevant working experience in a pharmaceutical manufacturing environment, preferably within a Quality/Quality Assurance function.
• Minimum of a Bachelor's degree in Pharmacy, Biochemistry, Microbiology, or another relevant science-related discipline.
• Certification in a quality-related discipline will be an added advantage.
• Training or knowledge in Statistics and Pharmaceutical Quality Management is desirable
• Good knowledge of GMP and pharmaceutical manufacturing operations.
• Strong documentation and report-writing skills.
• Good supervisory and people-management skills.
• Strong organisational skills with excellent attention to detail and report writing.