Job Purpose

Manage QC operations at a Pharma Factory to ensure compliance with approved specifications and GMP requirements. Oversee laboratory testing, validation and stability studies, and approve or reject materials, intermediates and bulk products.

Key Responsibilities

Quality Control & Testing

• Ensure all required chemical, physical and microbiological testing is completed; approve analytical results and accept or reject raw materials, packaging materials, intermediates and bulk products.
• Coordinate with Production and QA on in-process controls, manufacturing environment monitoring and quality decisions.

Laboratory Operations & Safety

• Maintain Good Quality Control Laboratory Practices, laboratory facilities and equipment, including calibration and maintenance.
• Evaluate and recommend laboratory equipment; ensure occupational health, safety and proper waste handling.

Methods, Validation & Stability

• Approve specifications, sampling instructions, analytical methods, SOPs and work instructions.
• Ensure appropriate analytical method, process and cleaning validations; oversee stability monitoring and approve relevant QC and Product Development methods, validation and stability reports.
• Provide QC data and documentation to support regulatory submissions.

GMP Compliance & Quality Systems

• Participate in GMP inspections and implement corrective action plans.
• Approve departmental Change Controls, NCRs and Deviations; coordinate with QA, Production and R&D on quality procedures and documentation.

Contractor Management

• Approve and monitor analytical contracts; evaluate contractor capabilities and recommend outsourced manufacturing and testing activities against company quality requirements.

Team, Budget & Reporting

• Train and develop QC personnel and relevant departments; manage performance evaluations and administrative approvals.
• Prepare monthly QC reports and the annual departmental budget.

Requirements

Education

• Bachelor’s degree in Pharmacy; registered pharmacist.

Experience

• 7–10 years of pharmaceutical QC experience.
• Experience in analytical methods, laboratory equipment qualification, validation and stability testing.
• Knowledge of pharmaceutical manufacturing, including tablets and capsules.

Skills

• Proficiency in chemical, physical and microbiological testing, including HPLC, GC and FTIR.
• Strong knowledge of GMP, GLP, relevant ISO standards, HSE and Halal requirements.
• Ability to review and approve QC specifications, SOPs, protocols and reports.
• Strong leadership, laboratory management, problem-solving and cross-functional coordination skills.