Assistant Manager, Validation

Essential Functions:

• Prepare and review Validation Master Plan (VMP) in alignment with site validation strategy and regulatory requirements.
• Monitor and review qualifications of equipment, systems, and utilities, including HVAC, purified water, and compressed air systems.
• Oversee and support process validation activities including protocol preparation, execution, data compilation, and report finalization.
• Review validation protocols and reports for equipment, cleaning, facility, utility, and computerized systems.
• Ensure validation lifecycle management and periodic re-validation as per established schedule.
• Initiate and review change controls, deviations, CAPAs related to validation activities.
• Conduct and support failure investigations and implement robust corrective/preventive actions.
• Ensure adherence to regulatory expectations (USFDA, EU, WHO, etc.) in all validation activities.
• Maintain all validation documentation as per data integrity and Good Documentation Practices (GDP).
• Ensure timely execution and review of cleaning validation and verification activities.
• Participate in risk assessment (FMEA, HAZOP) and quality risk management related to validation.
• Train QA and production personnel on validation concepts and GMP requirements.
• Coordinate with cross-functional teams (Engineering, Production, QC, IT) to ensure validation readiness.
• Participate in regulatory, internal, and third-party audits as validation SME (Subject Matter Expert).

Additional Responsibilities:

• Ensure timely review of protocols and reports related to new equipment, software, or process changes.
• Support technology transfer and new product introduction (NPI) by evaluating validation needs.
• Participate in the qualification of laboratory instruments and computerized systems (CSV).
• Implement and monitor continuous improvement initiatives within the validation domain.
• Drive audit preparedness by ensuring compliance with site validation SOPs and regulatory expectations.
• Support creation and revision of validation-related SOPs.
• Act as a mentor and guide for junior validation staff.
• Ensure timely tracking and closure of validation-related quality events in QMS.
• Establish and monitor key performance indicators (KPIs) for validation activities.
• Collaborate with corporate validation and regulatory teams for updates and global alignment.

Skills:

• Validation Master Planning – Advanced
• Equipment/Utility Qualification – Advanced
• Process/Cleaning Validation – Advanced
• Deviation & CAPA Handling – Advanced
• Change Control Management – Intermediate to Advanced
• Knowledge of HVAC, Water & Utility Systems – Advanced
• Current Regulatory Expectations (USFDA/EU/WHO etc.) – Advanced
• Failure Investigation & Root Cause Analysis – Intermediate
• Documentation Review & Audit Preparation – Advanced
• Cross-functional Collaboration & Team Leadership – Intermediate to Advanced.

Qualifications :

Education:

• M.Sc. – Chemistry – Preferred
• B. Pharm – Required
• M. Pharm – Preferred

Experience:

• 10 to 15 years of relevant experience in Validation QA in pharmaceutical/API/Formulation manufacturing