Senior Manager Quality Control

The Senior Manager – Quality Control will lead the Quality Control function at the manufacturing site, ensuring timely and compliant testing and release of raw materials, in-process samples, intermediates and finished products. The role is responsible for laboratory excellence, regulatory compliance, data integrity, inspection readiness and continuous improvement while providing leadership to the QC team.

Key Responsibilities

Laboratory Operation

• Lead all Quality Control activities at the manufacturing site
• Plan and allocate daily analytical activities to ensure timely testing and product release
• Review and approve analytical records, test results, Certificates of Analysis (CoA), specifications and Methods of Analysis (MoA)
• Authorise release of raw materials, intermediates and finished products
• Ensure optimum utilisation of laboratory resources, manpower and analytical instruments

Quality Systems & Compliance

• Maintain compliance with GMP, ISO, customer and applicable regulatory requirements
• Ensure adherence to ALCOA+ principles and Data Integrity requirements
• Review and approve QC SOPs, specifications, protocols and controlled documents
• Lead investigations related to OOS, OOT, deviations and laboratory incidents, ensuring timely CAPA implementation
• Ensure analytical method validation, verification and transfer are executed in line with regulatory expectations

Laboratory Management

• Ensure calibration, qualification and preventive maintenance of laboratory instruments and equipment
• Monitor laboratory documentation, instrument logs, reference standards, reagents and consumables
• Manage external laboratory testing, vendor performance and associated costs

Leadership & Continuous Improvement

• Lead, mentor and develop the QC team through technical, GMP and safety training
• Maintain the laboratory in a constant state of audit and inspection readiness, supporting customer and regulatory audits
• Promote laboratory safety, EHS compliance and good housekeeping practices
• Drive continuous improvement initiatives to enhance laboratory efficiency, quality and turnaround time
• Collaborate effectively with Production, QA, Engineering, Supply Chain and R&D to support business objectives

Qualifications

• M.Sc. in Chemistry / Analytical Chemistry / Organic Chemistry or equivalent. PhD will be an added advantage

Experience

• 12–18 years of Quality Control experience in a pharmaceutical, specialty chemicals or CDMO environment
• Minimum 5 years in a leadership role managing Quality Control laboratories
• Strong experience in analytical chemistry and instrumental techniques such as HPLC, GC, LC-MS, ICP-MS, KF etc.
• Experience in customer/regulatory audits and sound knowledge of GMP, ISO and Data Integrity requirements