Job Description

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