Head of Quality Control

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

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.

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