Executive, Pharmaceutical Validation

Duopharma Biotech Bhd Group of Companies.; Klang City; On-site; MYR 120,000 - 180,000; Full time

Job summary

Duopharma Biotech Berhad in Malaysia seeks a Validation Specialist to execute qualification activities for a new sterile facility, ensuring cGMP compliance and adherence to the Validation Master Plan.

You will perform PQs for cleanroom HVAC, utilities, equipment, and CSV for GxP systems, coordinate with Engineering, Production, QC, and QA, and support audits and regulatory inspections.

Qualifications

• Bachelor’s degree in a relevant field and GMP/Validation knowledge.
• Minimum 3 years of pharmaceutical validation experience in sterile environments.
• Exposure to audits/regulatory inspections and QRM principles.

Responsibilities

• Execute facility and utility validation for sterile manufacturing.
• Perform equipment qualification including IQ/OQ/PQ activities.
• Support CSV of GxP systems and risk assessments.
• Coordinate with Engineering, Production, QC, QA and Projects.
• Maintain documentation for cGMP compliance and audit readiness.

Skills

cGMP

Validation

Sterile manufacture

Quality systems

Risk assessment

Education

Bachelor’s Degree in Pharmacy, Biotechnology, Chemical Engineering or related field

Tools

IQ/OQ/PQ protocols

GxP systems

BMS/EMS

Job description

Job Summary

You will be responsible for executing validation activities for a new sterile manufacturing facility, ensuring compliance with cGMP, regulatory requirements, and internal validation standards in accordance with the Validation Master Plan.

Key Responsibilities

You will support validation activities across facilities, utilities, equipment, and systems within a sterile pharmaceutical environment.

1. Facility & Utility Validation

Execute performance qualification (PQ) for cleanroom HVAC systems in compliance with EU GMP Annex 1 sterile requirements

Perform validation for utilities including Purified Water (PW), Water for Injection (WFI), clean steam, compressed air, and nitrogen systems

2. Equipment Qualification

Perform qualification of manufacturing equipment including autoclaves, depyrogenation tunnels, vial washing machines, filling & sealing machines, and isolators/RABS

Execute IQ, OQ, and PQ protocols

Prepare traceability matrices

3. Computer System Validation (CSV)

Validate GxP systems such as BMS and EMS

Support risk assessments and validation lifecycle documentation

4. Cross-Functional Coordination

Coordinate with Engineering, Production, QC, QA, and Project teams

Support technology transfer activities

Assist in deviation investigations and CAPA implementation

5. Compliance & Documentation

Ensure validation and qualification documents are properly maintained in compliance with cGMP and GDPMD requirements

Support audit readiness and regulatory inspections

Perform any additional duties assigned by management

Requirements

Qualifications

Bachelor’s Degree in Pharmacy, Biotechnology, Chemical Engineering, or related field

Additional certification in GMP or Validation is an added advantage

Experience

Minimum 3 years of experience in pharmaceutical validation

Experience in sterile or injectable manufacturing environment is preferred

Exposure to audits and regulatory inspections

Knowledge of Quality Risk Management (QRM)

Experience in greenfield projects is an advantage

Technical Skills & Knowledge

Strong understanding of sterile manufacturing processes

Knowledge of aseptic process validation and media fills

Hands-on experience with HVAC qualification and cleanroom standards

Familiarity with EU GMP Annex 1 (latest revision)

Strong documentation and report writing skills

Risk-based validation approach

Good analytical and problem-solving skills

Good communication and teamwork skills

Ability to work across multiple departments

Detail-oriented with strong compliance mindset

Eager to learn and develop professionally

About Duopharma Biotech Berhad

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.