Executive, Quality Assurance

Duopharma Biotech Bhd Group of Companies.; Bandar Baru Bangi; On-site; MYR 56,000 - 89,000; Full time

Job summary

Duopharma Biotech Berhad is seeking a Quality Assurance Executive to ensure GMP, QMS compliance and PIC/S guidelines across pharmaceutical manufacturing operations. You will support the QA department's compliance initiatives and vendor quality management within the Duopharma group.

The role involves assisting in audits, CAPA, change control, and collaboration with cross-functional teams to maintain regulatory readiness and product quality.

Qualifications

• Bachelor's degree in Pharmacy or related science discipline.
• Minimum 2–3 years in GMP-regulated pharmaceutical manufacturing.
• Strong knowledge of GMP, QMS, and PIC/S guidelines.

Responsibilities

• Assist in start-up of Compliance arm of QA Department across Duopharma subsidiaries.
• Assist in implementation of supplier and vendor quality management and audit programs per QMS requirements.
• Assist in evaluating quality management effectiveness and provide metrics for QA reporting.

Skills

GMP knowledge

QMS knowledge

PIC/S guidelines

Batch record review

Quality investigations

CAPA & change control

SAP

Microsoft Office

Pharma manufacturing processes

Analytical skills

Communication skills

Education

Bachelor's Degree in Pharmacy/Pharmaceutical Sciences or related

Tools

SAP

Microsoft Office

Job description

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. .

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.

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.

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.

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.

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.

What can I earn as a Quality Assurance Executive

Duopharma Biotech Berhad began with the establishment of Duopharma (M) Sdn Bhd in 1978. Incorporated in 2000, we are one of Malaysia’s leading pharmaceutical companies listed on the Bursa Malaysia's Main Market. We specialise in manufacturing, R&D, and marketing of generic drugs and consumer healthcare products (CHAMPS®, FLAVETTES® & UPHAMOL) as well as biosimilars (ERYSAA®, Basalog One®). As a pioneer in halal pharmaceuticals, we were the 1st to receive JAKIM certification for OTC and prescription products under MS2424:2019. Headquartered in Kuala Lumpur, we operate three GMP-certified plants (Klang, Bangi & Glenmarie) and have a growing presence in Indonesia, the Philippines and Singapore.