Senior Executive Pharmaceutical Validation

Senior Executive, Validation

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

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Job Summary

This role is responsible for planning, executing, and managing validation activities for a new sterile manufacturing facility. You will ensure compliance with cGMP requirements, regulatory standards, and internal validation frameworks in line with the Validation Master Plan.

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Key Responsibilities

You will play a critical role in establishing and maintaining validation systems for a sterile pharmaceutical environment.

1. Facility & Utility Validation

• Develop and execute validation protocols for HVAC systems (cleanroom ISO classification)
• Validate water systems (PW, WFI), compressed gases (CDA, Nitrogen), and clean steam systems
• Perform SIP qualification activities

2. Equipment Qualification

• Qualify manufacturing equipment including autoclaves, depyrogenation tunnels, vial washing machines, filling & sealing machines, and isolators/RABS
• Execute IQ, OQ, and PQ protocols
• Prepare traceability matrices and perform documentation review

3. Computer System Validation (CSV)

• Validate GxP systems such as BMS and EMS
• Conduct risk assessments and manage validation lifecycle documentation

4. Cross-Functional Coordination

• Work closely with Engineering, Production, QC, QA, and Project teams
• Participate in FAT and SAT activities for new equipment
• Support technology transfer processes
• Assist in deviation investigations and CAPA implementation

5. Compliance & Documentation

• Ensure all validation and qualification documents are maintained in accordance with cGMP and GDPMD requirements
• Support audit readiness and regulatory inspections
• Perform any additional duties assigned by management

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Requirements

Qualifications

• Bachelor’s Degree in Pharmacy, Biotechnology, Chemical Engineering, or related field
• Additional certification in GMP or Validation is an advantage

Experience

• Minimum 5 years of experience in pharmaceutical validation
• Experience in greenfield sterile plant setup is highly preferred
• Exposure to regulatory audits
• Experience in injectable or biologics manufacturing environments
• Knowledge of Quality Risk Management (QRM)

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Technical Skills & Knowledge

• Strong expertise in aseptic processing and sterilization validation
• Hands-on experience with HVAC qualification and cleanroom standards
• Familiarity with Annex 1 (latest revision) requirements
• Experience in aseptic process validation and media fills
• Strong documentation and report writing skills
• Risk-based validation approach
• Strong analytical and problem-solving capabilities

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Competencies

• Strong communication and stakeholder management skills
• Ability to work across cross-functional teams
• Detail-oriented with strong compliance mindset
• Proactive and eager to continuously learn and improve