Head of Quality Control

Ranbaxy (Malaysia) Sdn Bhd a SUN PHARMA company; Sungai Petani; On-site; MYR 150,000 - 200,000; Full time

Job summary

A leading pharmaceutical company in Sungai Petani, Kedah, is seeking a Head of Quality Control. In this role, you will lead quality control initiatives ensuring compliance and product integrity. Candidates should have 15-20 years of QA experience, strong knowledge of GMP/GLP, and excellent leadership skills. The company offers a competitive salary and comprehensive benefits package.

Benefits

Competitive salary

Comprehensive benefits package

Opportunities for career development

Qualifications

• 15-20 years of QA experience in the pharmaceutical industry, with at least 5 years in a leadership role.
• Strong knowledge of GMP/GLP, stability testing, and microbiology testing.
• Experience with OOS/OOT, method validation/transfer, and regulatory inspections.

Responsibilities

• Lead and manage the QC department including Analysts, microbiologists, and lab technicians.
• Oversee analytical testing for raw materials, in-process samples, and finished products.
• Maintain compliance with cGMP/cGLP and local regulatory requirements.
• Develop and implement QC SOPs and validation programs.
• Train and mentor QC staff.

Skills

GMP knowledge

Analytical techniques (HPLC, GC, UV, titration)

Leadership skills

Communication skills

Problem-solving skills

Laboratory information systems

PowerPoint proficiency

Education

Bachelor's or master's degree in pharmacy, Chemistry, Pharmaceutical Science, or related discipline

Job description

About the role

Ranbaxy (Malaysia) Sdn Bhd, a SUN PHARMA company, is seeking a talented and experienced professional to join our team as a Head of Quality Control. In this full-time role, you will be responsible for leading and overseeing the company's Quality Control initiatives at our facility plant in Sungai Petani, Kedah.

We are a leading pharmaceutical company committed to delivering high-quality, safe, and effective healthcare solutions. With a robust pipeline and a global footprint, we are seeking a visionary Head of Quality Control to lead our QC operations and uphold the highest standards of regulatory compliance and product integrity.

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.
• 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.

Requirements

• Bachelor's or master's degree in pharmacy, Chemistry, Pharmaceutical Science, or related discipline.
• 15-20 years of QA experience in the pharmaceutical industry, with at least 5 years in a leadership 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
• Proficient in power point presentations

What we offer

At Ranbaxy (Malaysia) Sdn Bhd a SUN PHARMA company', we are committed to providing our employees with a rewarding and fulfilling work experience. We offer a competitive salary, comprehensive benefits package, and opportunities for career development. Our company culture promotes collaboration, innovation, and a healthy work-life balance.

Ranbaxy (Malaysia) Sdn Bhd is an equal opportunities employer and welcomes applications from all qualified candidates.