Quality Assurance Manager

BTI Executive Search Pte Ltd; Sungai Petani; On-site; MYR 90,000 - 120,000; Full time

Job summary

A leading executive search firm in Malaysia is seeking an experienced QA Manager to oversee the QA department. Candidates should have a degree in Pharmacy or Chemistry and extensive experience in the pharmaceutical sector, including leadership roles. The role involves ensuring regulatory compliance and managing quality systems, making it essential for applicants to have strong knowledge of GMP and ICH guidelines.

Qualifications

• 15-20 years of QA experience in the pharmaceutical industry.
• At least 5 years in a leadership role.
• Strong knowledge of GMP, ICH guidelines, and regulatory frameworks.

Responsibilities

• Lead and manage the QA department, including team development and performance.
• Ensure compliance with local and international regulatory requirements.
• Oversee Quality Management System including CAPA, deviations, change control.
• Serve as the primary contact for regulatory inspections and customer audits.
• Execute lot disposition of Finished Product for distribution.

Skills

Leadership

Communication

Problem-solving

Knowledge of GMP

Presentation skills

Education

Bachelor’s or Master’s degree in Pharmacy, Chemistry, or related field

Job description

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.

Qualifications

• Bachelor’s or Master’s degree in Pharmacy, Chemistry, or related field.
• 15-20 years of QA experience in the pharmaceutical industry, with at least 5 years in a leadership role.
• Strong knowledge of GMP, ICH guidelines, and regulatory frameworks.
• Proven track record in managing audits and regulatory inspections (NPRA).
• Excellent leadership, communication, and problem-solving skills.
• Proficient in power point presentation.