Head of Quality Assurance

Sun Pharma; Alor Merah; On-site; MYR 250,000 - 300,000; Full time

Job summary

A leading pharmaceutical company in Malaysia is seeking a Head of Quality Assurance. This full-time role involves leading the QA department, ensuring compliance with GMP and local regulations, and driving a culture of quality across operations. Candidates should have 15-20 years of experience in QA, with at least 5 years in leadership. This position offers competitive remuneration and opportunities for professional growth within a supportive work environment.

Benefits

Competitive remuneration

Opportunities for professional development

Supportive work environment

Qualifications

• 15-20 years of QA experience in the pharmaceutical industry.
• At least 5 years in a leadership role.
• Extensive knowledge of GMP and audit management.

Responsibilities

• Lead and manage the QA department.
• Ensure compliance with regulatory requirements.
• Oversee Quality Management System.

Skills

Leadership in QA

Regulatory compliance

Analytical skills

Interpersonal skills

Education

Degree in Pharmacy or Pharmaceutical Sciences

Tools

PowerPoint

Job description

Ranbaxy (Malaysia) Sdn Bhd, a SUN PHARMA company, is seeking a talented and experienced professional to join our team as a Head of Quality Assurance Department. In this full-time role, you will be responsible for leading and overseeing the company's Quality Assurance 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 Assurance to lead our QA operations and uphold the highest standards of regulatory compliance and product integrity.

As the Head of QA, you will oversee all aspects of quality assurance across manufacturing, packaging, testing and distribution. You will be responsible for ensuring compliance with GMP, regulatory guidelines, and internal quality standards, while driving continuous improvement and fostering a culture of quality.

Key responsibilities

• Lead and manage the QA department, including team development and performance
• Ensure compliance with local and international regulatory requirements (e.g. NPRA and PIC/S)
• Oversee Quality Management System including CAPA, deviations, change control etc
• Work in partnership with Manufacturing, Engineering, and QC to increase knowledge and understanding of cGMPs and improve practices and procedures.
• Serve as the primary contact for regulatory inspections and customer audits
• To ensure the cGMP compliance in all operational activities for manufacturing of drug products.
• Maintain and update all documents in accordance with statutory/regulatory requirements.
• Ensure all GxP computerized systems are validated in compliance with the quality policies, standards and procedures and are maintained in validated state throughout the lifecycle.
• Provides appropriate training and development to support staff to meet their respective job responsibilities.
• To execute lot disposition (release or rejection) of Finished Product for distribution.

What we’re looking for

• Degree in Pharmacy, Pharmaceutical Sciences, or a relevant field
• 15-20 years of QA experience in the pharmaceutical industry, with at least 5 years in a leadership role
• Extensive knowledge of good manufacturing practices (GMP), ICH guidelines and regulatory requirements
• Proven track record in managing audits and regulatory inspections (NPRA)
• Strong analytical and problem-solving skills with the ability to identify and address quality-related issues
• Excellent communication and interpersonal skills to effectively collaborate with cross-functional team
• 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 supportive work environment. We offer competitive remuneration, opportunities for professional development, and a range of benefits to support your well-being. Join our team and be a part of our mission to deliver high-quality pharmaceutical products to our customers.

If you are ready to take on this exciting challenge, apply now to be considered for the Head of Quality Assurance Department position.