Amneal Pharmaceuticals - Manager - Validation Quality Assurance

JOB 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.

Qualifications:

Education:

B.Sc. 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.