Quality Control Manager

BTI Executive Search Pte Ltd; Sungai Petani; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading recruitment firm is seeking a Quality Control Manager for a pharmaceutical company in Malaysia. The role involves leading the QC department, overseeing all analytical testing, and ensuring compliance with regulatory standards. Candidates should have at least 15 years of experience in QC laboratories and 5 years in a managerial role. Excellent leadership and communication skills are a must for this position.

Qualifications

• At least 15 years’ experience in pharmaceutical QC laboratories.
• Minimum of 5 years in managerial role.
• Experience handling OOS/OOT and regulatory inspections.

Responsibilities

• Lead and manage the QC department including staff.
• Oversee analytical testing and maintain compliance with guidelines.
• Develop and implement QC SOPs and support best practices.

Skills

Leadership

Communication

Problem-solving

Knowledge of GMP/GLP

Analytical techniques (HPLC, GC, UV, titration)

Education

Bachelor or Master Degree in Pharmacy, Chemistry, Pharmaceutical Science

Tools

Laboratory information systems

Job description

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 PowerPoint presentations.

Application Questions

• Which of the following statements best describes your right to work in Malaysia?
• What's your expected monthly basic salary?
• Which of the following types of qualifications do you have?
• How many years' experience do you have as a Quality Control Manager?
• Have you worked in a pharmacy before?
• How many years' experience do you have in a quality control (QC) role?