Manager - Validation (QA) API Mfg. at Raks Pharma, Dahej.

Manager, Validation Quality Assurance | API Manufacturing

Description :

Manager Validation QA is responsible for overseeing, planning, and reviewing all validation activities, including equipment qualification, system validation, process validation, and cleaning validation, in compliance with regulatory and internal quality standards. This role ensures that all manufacturing and utility systems are validated and remain in a state of control, through risk-based approaches, robust documentation, and timely review of protocols and reports. The position requires expertise in current regulatory requirements and the ability to lead audits, investigations, and quality improvement initiatives.

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.

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
  • Minimum 1 year in the current role

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.