Senior Executive Validation

About the role

The Senior Executive Validation leads the planning, execution, and reporting of process validation, hold‑time studies, and equipment qualification projects to ensure timely delivery and regulatory compliance within a pharmaceutical manufacturing environment.

Key responsibilities

• Plan, execute, and document process validation activities in line with GMP guidelines.
• Design and conduct hold‑time studies, including sampling plans, result evaluation, and report preparation.
• Qualify manufacturing and support equipment through Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Develop, review, and approve validation protocols, reports, and related SOPs.
• Participate in Aseptic Process Simulation (APS/Media Fill) studies and maintain thorough documentation.
• Perform data review and trend analysis to identify variability, deviations, or risks.
• Support internal and external audits/inspections with technical inputs.
• Coordinate with Production, QA, QC, and Engineering to ensure timely completion of validation tasks.
• Maintain validation master plans and periodically review validated systems.

Required profile

• M.Sc. in Chemistry/Applied Chemistry or Pharm‑D from an HEC‑recognized university.
• Minimum 2–3 years of experience in pharmaceutical validation and qualification.
• Strong knowledge of cGMP, FDA, EMA, and WHO regulatory requirements.
• Experience assessing validation‑related deviations, change controls, and CAPA implementation.

Required skills

• Process validation
• Hold‑time study design and execution
• Equipment qualification (IQ, OQ, PQ)
• Aseptic Process Simulation (APS) / Media Fill studies
• Data analysis and trend analysis
• cGMP compliance
• Regulatory knowledge (FDA, EMA, WHO)