Quality Control Manager

2 days ago

Sungai Petani, Kedah, Malaysia BTI Executive Search Pte Ltd Full time 100,000 - 150,000 per year

Key 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:


• Bachelor or Master Degree in Pharmacy, Chemistry, Pharmaceutical Science, or related discipline.


• At least 15 years' experience in pharmaceutical QC laboratories, with a minimum of 5 years in managerial role.


• Strong knowledge of GMP/GLP, stability testing, analytical techniques (HPLC, GC, UV, titration), and microbiology testing.


• Demonstrable experience handling OOS/OOT, method validation/transfer, and regulatory inspections.


• Excellent leadership, communication, and problem-solving skills.


• Proficient in laboratory information systems.


• Proficiency in Power point presentations.

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