Head of Quality Control

1 day ago

Sungai Petani, Kedah, Malaysia Ranbaxy (Malaysia) Sdn Bhd a SUN PHARMA company Full time

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.

What you'll be doing

  1. Lead and manage the QC department including Analysts, microbiologists, and lab technicians.
  2. Oversee analytical testing for raw materials, in-process samples, finished products, and stability studies.
  3. Approve release decisions for batches in accordance with specifications and SOPs.
  4. Maintain compliance with cGMP/cGLP, PIC/S guidelines and local regulatory requirements.
  5. 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.
  6. Manage laboratory quality systems: deviation handling, CAPA, change control, OOS/OOT investigations, and documentation control.
  7. Coordinate regulatory inspections and supplier audits; prepare QC for site visits and responses.
  8. Drive continuous improvement in test turnaround time, cost control, and method robustness.
  9. Budgeting and resource planning for QC equipment, consumables, calibration, and maintenance.
  10. Train and mentor QC staff; cultivate technical competence and Quality culture.
  11. Technology Transfer: Co-ordination w.r.t Analytical Method Transfer for technology transfer during new product launches.
  12. Pharmacopoeia Compliance: Pharmacopoeia review of specifications and STP's and ensure the compliance.
  13. 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.

What we're looking for

  1. Bachelor's or master's degree in pharmacy, Chemistry, Pharmaceutical Science, or related discipline.
  2. 15-20 years of QA experience in the pharmaceutical industry, with at least 5 years in a leadership role
  3. Strong knowledge of GMP/GLP, stability testing, analytical techniques (HPLC, GC, UV, titration), and microbiology testing.
  4. Demonstrable experience handling OOS/OOT, method validation/transfer, and regulatory inspections.
  5. Excellent leadership, communication, and problem-solving skills.
  6. Proficient in laboratory information systems
  7. 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.

Apply now for this exciting opportunity to be a part of our growing team

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