Location: Klang, Selangor

Company: Duopharma (M) Sdn Bhd

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.

Key Responsibilities

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

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

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

Computer System Validation (CSV)

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

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

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

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)

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

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

Senior Executive Pharmaceutical Validation