Validation Section Head

We are looking for an experienced Validation Section Head to lead and manage the Validation function and ensure compliance with pharmaceutical and vaccine GMP requirements.

The role will be responsible for developing and maintaining the Validation Master Plan (VMP) and establishing science- and risk-based validation strategies covering facilities, utilities, equipment, computerized systems, processes, and cleaning programs throughout their lifecycle.

The Validation Section Head will provide technical oversight and approval of qualification and validation activities, ensuring compliance with EU-GMP Annex 1, EU-GMP Annex 15, WHO Vaccine GMP Guidelines, WHO TRS 961, FDA 21 CFR Parts 210 & 211, ICH Q8/Q9/Q10, WHO GDP, and Data Integrity requirements.

The role will lead the Validation team and collaborate closely with QA, Production, QC, Engineering, IT, Maintenance, and other functions to ensure validation activities support product quality, GMP compliance, operational readiness, and regulatory expectations.

• Lead and manage the Validation Section to ensure compliance with pharmaceutical and vaccine GMP requirements.
• Develop, implement, maintain, and periodically review the Validation Master Plan (VMP).
• Establish validation strategies aligned with business objectives, regulatory expectations, and Quality Risk Management principles.
• Ensure effective validation lifecycle management for facilities, utilities, equipment, computerized systems, manufacturing processes, and cleaning programs.
• Provide technical oversight and approval of qualification and validation activities, including DQ, FAT, SAT, IQ, OQ, PQ, and requalification.
• Review and approve URS, Validation Plans, protocols, reports, risk assessments, validation assessments, and traceability matrices.
• Ensure qualification and validation activities are scientifically justified, risk-based, and compliant with applicable regulations.
• Lead qualification programs for HVAC systems, cleanrooms, controlled areas, PW systems, WFI systems, compressed air systems, and other critical utilities.
• Review and approve temperature mapping studies for warehouses, cold rooms, refrigerators, freezers, and vaccine storage areas.
• Ensure compliance with WHO TRS 961, WHO GDP, EU-GMP Annex 1, EU-GMP Annex 15, FDA 21 CFR Parts 210 & 211, Data Integrity requirements, and ICH Q8/Q9/Q10.
• Establish and maintain Process Validation and Continued Process Verification (CPV) programs.
• Lead the lifecycle management of Cleaning Validation activities.
• Review validation strategies, acceptance criteria, sampling approaches, and scientific rationale for process and cleaning validation.
• Provide technical oversight of Computerized System Validation (CSV) activities in accordance with GAMP 5 principles.
• Ensure computerized systems supporting GMP operations are appropriately validated and maintained throughout their lifecycle.
• Ensure validation requirements are integrated into Change Control, Deviation Management, CAPA, Risk Management, and Technology Transfer activities.
• Review validation documentation, including risk assessments, protocols, traceability matrices, and reports.
• Identify validation gaps and risks and ensure appropriate corrective and preventive actions are implemented.
• Lead responses to internal, customer, and regulatory audit observations related to qualification and validation.
• Support regulatory inspections by providing validation documentation, evidence, and technical justification.
• Plan and prioritize multiple validation projects while ensuring quality, compliance, and timely completion.
• Lead, coach, and develop Validation team members and ensure effective allocation of resources and responsibilities.
• Stay updated on regulatory requirements, industry best practices, and emerging expectations related to pharmaceutical and vaccine validation.

Education:

1. Bachelor’s degree in Microbiology, Biochemistry, Chemistry, Veterinary Medicine, Pharmacy, Engineering, or a related scientific/technical discipline.
2. Postgraduate qualification in Pharmaceutical Quality, Validation, Engineering, Quality Management, or a related field is preferred.

Experience

1. Minimum 5 years of relevant experience in Validation/Qualification, preferably within pharmaceutical, biopharmaceutical, vaccine, or other GMP-regulated manufacturing environments.
2. Previous experience in a Senior Validation, Validation Lead, or Validation Supervisory role is preferred.
3. Strong experience with DQ, FAT, SAT, IQ, OQ, PQ, and requalification activities.
4. Strong experience in qualification of HVAC, cleanrooms, controlled areas, PW, WFI, compressed air, and other GMP utilities.
5. Experience in temperature mapping and qualification of temperature-controlled storage areas is preferred.
6. Strong knowledge of Process Validation, Continued Process Verification (CPV), and Cleaning Validation.
7. Experience integrating validation requirements with Change Control, Deviations, CAPA, Risk Management, and Technology Transfer.
8. Strong experience in validation documentation, technical review, audits, and inspection readiness.

Technical Knowledge:

1. Strong knowledge and practical experience with EU-GMP Annex 1 and EU-GMP Annex 15.
2. Knowledge of WHO Vaccine GMP Guidelines, WHO TRS 961, WHO GDP, FDA 21 CFR Parts 210 & 211, and ICH Q8, Q9, and Q10.
3. Understanding of Computerized System Validation (CSV) and GAMP 5.
4. Strong knowledge of Quality Risk Management and ICH Q9 principles.
5. Knowledge of QHSE systems is an advantage.

Skills & Competencies:

1. Strong leadership and people management skills.
2. Strong analytical, investigation, troubleshooting, and problem-solving skills.
3. Strong project coordination, planning, and prioritization skills.
4. Ability to manage multiple validation projects simultaneously.
5. Excellent communication and presentation skills.
6. Good command of English and Microsoft Office.

• Social, Medical and Life Insurance
• Pension Coverage
• Profit Share
• Quarterly Balanced Scorecard
• Transportation from certain points