Quality Control (QC) Manager

Position Summary

We are seeking a highly qualified QC Manager to join our pharmaceutical manufacturing facility. The ideal candidate must be a licensed Pharmacist with strong experience in sterile pharmaceutical manufacturing and Quality Control operations, ensuring compliance with GMP & GLP standards.

Qualifications

• Bachelor’s degree in Pharmacy (mandatory).
• Maximum 5 years of experience as a QC Manager in a pharmaceutical manufacturing company.
• Proven experience in sterile product manufacturing (mandatory).
• Strong knowledge of GMP, GLP, and regulatory requirements.
• Excellent leadership, analytical, and documentation skills.

Key ResponsibilitiesLaboratory & Quality Management

• Plan, supervise, and execute activities in Chemistry, Microbiology, and R&D laboratories.
• Ensure full compliance with GLP & GMP standards across all QC operations.
• Review and investigate Out of Specification (OOS) results and implement corrective actions.
• Report non-conformities and corrective actions to the General Manager.
• Implement and maintain QC policies, SOPs, and procedures.

Reporting & Documentation

• Prepare and submit monthly QC reports including analytical data evaluation and troubleshooting.
• Ensure proper documentation, logbooks, records, and archiving of QC documents.
• Maintain deviation reports, OOS logs, and trend analysis records.

Testing & Approval

• Approve physical, chemical, and microbiological analysis of:

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• Raw materials
• Primary & secondary packaging materials
• In-process and finished products (COA approval)

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• Monitor daily quality of Raw Water, Purified Water, and Water for Injection (WFI).

Method Development & Stability

• Develop and validate analytical methods.
• Prepare and manage stability studies and stability chambers.
• Develop stability plans for new and existing products.

Equipment & Inventory Management

• Ensure availability, calibration, and maintenance of QC laboratory instruments.
• Manage inventory of chemicals, reagents, and consumables.

Training & Team Management

• Train new staff on SOPs and laboratory equipment.
• Ensure continuous training of QC personnel based on operational needs.
• Evaluate QC staff performance.

Cross-Functional & Compliance Activities

• Coordinate with Production, QA, Warehouse, and R&D for smooth operations.
• Participate in vendor audits for raw and packaging material approval.
• Monitor storage conditions for raw materials and reference samples.

Budget & Cost Control

• Prepare and manage the annual QC budget.
• Review consumables cost and ensure cost-effective QC operations.

Key Skills & Competencies

• Strong leadership and team management skills
• Excellent analytical and problem-solving ability
• High attention to detail
• Strong regulatory and compliance knowledge
• Effective communication and reporting skills

Work Location

• Pharmaceutical Manufacturing Facility (Sterile Products)

Many benefits:

· Generous salary, travel tickets, health insurance, meals

Job Type: Full-time