Qualifications, Skills and Experience

• Bachelor's degree in Chemistry, Pharmacy, Pharmaceutical Sciences, Microbiology, Laboratory Technology, or a related scientific field.
• Minimum 7 years of QA/QC experience in pharmaceutical manufacturing, including at least 5 years in a managerial role.
• Strong experience in pharmaceutical QC testing, analytical methods, laboratory operations, and quality management systems.
• In-depth knowledge of cGMP, GLP, regulatory compliance, SOPS, and pharmaceutical quality standards.
• Experience in method validation, stability studies, equipment qualification, audits, and quality investigations.
• Strong understanding of QC laboratory instruments, analytical equipment, and quality documentation systems.
• Proven leadership, analytical, problem-solving, organizational, and communication skills.
• Proficiency in Microsoft Office and laboratory reporting systems.

Key Responsibilities

• Oversee QC laboratory operations, ensuring timely testing of raw materials, packaging materials, intermediates, and finished products.
• Develop and maintain QC standards, specifications, SOPs, testing procedures, and quality documentation.
• Ensure compliance with cGMP, GLP, regulatory requirements, and data integrity standards.
• Manage analytical method validation, stability testing, equipment calibration, qualification, and laboratory maintenance.
• Review batch records, analytical results, and approve or reject materials and products based on QC findings.
• Lead investigations into deviations, out-of-specification results, customer complaints, and corrective actions.
• Coordinate internal and external audits, regulatory inspections, quality risk management, and continuous improvement initiatives.
• Manage departmental budgets, laboratory resources, performance targets, and QC team training and development.