Quality Control Manager

Responsibilities

• Lead and manage the QC department including Analysts, microbiologists, and lab technicians.
• Oversee analytical testing for raw materials, in-process samples, finished products, and stability studies.
• Approve release decisions for batches in accordance with specifications and SOPs.
• Maintain compliance with cGMP / cGLP, PIC / S guidelines and local regulatory requirements.
• Develop and implement QC SOPs, test methods, and validation programs. Support best practices in Laboratory in terms of integrity, accuracy and adequacy of the testing and documentation.
• Manage laboratory quality systems : deviation handling, CAPA, change control, OOS / OOT investigations, and documentation control.
• Coordinate regulatory inspections and supplier audits; prepare QC for site visits and responses.
• Drive continuous improvement in test turnaround time, cost control, and method robustness.
• Budgeting and resource planning for QC equipment, consumables, calibration, and maintenance.
• Train and mentor QC staff; cultivate technical competence and Quality culture.
• Technology Transfer : Co-ordination w.r.t Analytical Method Transfer for technology transfer during new product launches.
• Pharmacopoeia Compliance : Pharmacopoeia review of specifications and STP’s and ensure the compliance.
• Ensure the laboratory computerized systems are validated in compliance with the quality policies, standards and procedures and are maintained in validated state throughout the lifecycle.

Qualifications

Application Questions

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