Executive, Pharmaceutical Validation

Duopharma Biotech; Klang City; On-site; MYR 120,000 - 180,000; Full time

Job summary

Duopharma (M) Sdn Bhd is seeking an Executive, Validation to lead validation activities for a new sterile manufacturing facility, ensuring cGMP compliance and alignment with the Validation Master Plan.

You will perform PQ for cleanroom HVAC, validate utilities and equipment, support CSV, coordinate with multi-disciplinary teams, and maintain documentation for regulatory inspections. Experience with EU GMP Annex 1 and GMP audits will be a plus.

Qualifications

• Bachelor’s degree in Pharmacy, Biotechnology, Chemical Engineering, or related field.
• Certification in GMP or Validation is an added advantage.

Responsibilities

• Execute PQ for cleanroom HVAC systems in compliance with EU GMP Annex 1 sterile requirements.
• Validate utilities including Purified Water (PW), Water for Injection (WFI), clean steam, compressed air and nitrogen systems.
• Coordinate with Engineering, Production, QC, QA and Project teams.
• Validate GxP systems such as BMS and EMS; support risk assessments and validation lifecycle documentation.
• Maintain validation and qualification documents to meet cGMP and GDPMD requirements and support audits.

Skills

Validation

cGMP

Regulatory compliance

Documentation

Risk management

Equipment qualification

HVAC qualification

GxP systems

QA collaboration

Education

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

Job description

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Executive, Validation

Location: Klang, Selangor
Company: Duopharma (M) Sdn Bhd

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
• Support SIP qualification activities

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

Competencies

• Good communication and teamwork skills
• Ability to work across multiple departments
• Detail-oriented with strong compliance mindset
• Eager to learn and develop professionally