Executive, Quality Assurance

Executive, Quality Assurance

Location: Bandar Baru Bangi, Selangor
Company: Duopharma Manufacturing (Bangi) Sdn Bhd

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Job Summary

This role is responsible for ensuring compliance with Good Manufacturing Practice (GMP), Quality Management Systems (QMS), and PIC/S guidelines across pharmaceutical manufacturing operations. .

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Key Responsibilities

• Assist in the start-up of Compliance arm of the Quality Assurance Department in Duopharma within all Duopharma’s subsidiary companies.
• Assist in the implementation of suppliers and vendors quality management and audit programs to comply with requirements listed by the company’s Quality Management System (QMS) for the products or services provided to Duopharma.
• Assist the Assistant Manager/ Manager, Pharmacist in assessing and monitoring effectiveness in areas of Quality Management System (QMS) implementation and provide metrics for quality management reporting and helps to identify areas for further monitoring for improvements.
• Assist vendor selection and evaluation to ensure quality, safety and efficacy of product/services provided to Duopharma based on analysis and evaluation of data and information
• Assist in the implementation of New Source Evaluation to comply with requirements listed by the company’s Quality Management System (QMS) for the products or services provided to Duopharma.
• Assist in the implementation of Quality Agreements with Clients and maintain compliance to Quality Agreements.
• Assist in ensuring the responsibilities of the contract giver and contract acceptor are defined for contracted manufacturing and testing.

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Requirements

Qualifications

• Bachelor's Degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Biotechnology, Pharmaceutical Technology, or related science discipline.

Experience

• Minimum 2–3 years of experience in a GMP-regulated pharmaceutical manufacturing environment.

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Technical Skills & Knowledge

• Strong knowledge of Good Manufacturing Practice (GMP), Quality Management Systems (QMS), and PIC/S guidelines.
• Experience in batch record review, quality investigations, CAPA, and change control.
• Familiarity with SAP and Microsoft Office applications is an advantage.
• Good understanding of pharmaceutical manufacturing processes and regulatory requirements.

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Competencies

• Strong analytical and problem-solving skills.
• High attention to detail with a quality-focused mindset.
• Good communication and stakeholder management skills.
• Ability to work independently and collaborate effectively across functions.
• Well-organized, proactive, and committed to continuous improvement.

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Why Join Us?

• Be part of a growing pharmaceutical manufacturing facility specializing in Highly Active Pharmaceutical Ingredients (HAPI).
• Gain hands-on experience in pharmaceutical quality assurance and GMP compliance.
• Exposure to quality investigations, batch release, and regulatory inspection readiness.
• Opportunity to work closely with cross-functional teams in a highly regulated manufacturing environment.
• Career development opportunities within Quality Assurance and Pharmaceutical Manufacturing.