Assistant Manager, Validation

1 day ago

Dahej SIR Gujarat India Amneal Full time ₹ 12,00,000 - ₹ 24,00,000 per year
Description

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

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

 

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