QUALITY CONTROL (QC) MANAGER

Requirements

• Minimum Bachelor’s degree (S1) in Pharmacy or a related field; Pharmacist qualification is preferred.
• Minimum 5–7 years of experience in Quality Control, with at least 2–3 years of experience in a supervisory or managerial position within the pharmaceutical industry.
• Good understanding and hands-on experience in the implementation of CPOB/GMP, quality management systems, and applicable pharmaceutical industry regulations.
• Good understanding of the principles and execution of testing for raw materials, packaging materials, in-process products, bulk products, and finished products.
• Good understanding of analytical method validation/verification, laboratory equipment qualification, and product stability management.
• Strong knowledge of OOS (Out of Specification), OOT (Out of Trend), deviations, CAPA, change control, and laboratory investigations.
• Experience in participating in and supporting internal and external audits, including regulatory and customer audits.
• Strong analytical, problem-solving, decision-making, and leadership skills.
• Ability to manage teams, set work priorities, and ensure departmental targets are achieved.
• Detail-oriented, highly ethical, assertive, responsible, and able to work in an environment with high compliance standards.
• Proficiency in Microsoft Office and experience with laboratory systems/applications or Quality Management Systems (QMS) will be an advantage.

Responsibilities

• Lead and manage all Quality Control activities to ensure that materials, processes, and products meet established specifications and quality standards.
• Ensure that laboratory testing is performed in accordance with CPOB/GMP, SOPs, specifications, analytical methods, and applicable regulatory requirements.
• Supervise the testing of raw materials, packaging materials, in-process products, bulk products, finished products, and stability samples.
• Ensure the reliability, accuracy, and traceability of laboratory test results.
• Manage and ensure the proper execution of OOS/OOT investigations, deviations, CAPA, change control, and investigations related to laboratory test results.
• Ensure that all laboratory equipment is properly maintained and meets calibration, qualification, and maintenance requirements.
• Oversee the implementation of analytical method validation/verification and ensure that the methods used comply with applicable requirements.
• Review and approve documents, analytical results, investigation reports, and laboratory data within the scope of assigned authority.
• Ensure the implementation of data integrity principles throughout all laboratory activities.
• Prepare and ensure the QC department’s readiness for regulatory, customer, and internal audits.
• Identify risks and improvement opportunities within QC processes and develop continuous improvement programs.
• Develop, monitor, and evaluate QC departmental KPIs, including quality, testing turnaround time, productivity, and compliance.
• Provide regular reports to management regarding QC performance, test results, investigations, quality risks, and improvement plans.
• Ensure that all QC activities are properly documented and comply with Good Documentation Practice (GDP) and the company’s quality management system requirements.