Deputy Manager, Quality Validation at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

21 Jun, 26

Salary

0.0

Posted On

23 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Validation, Equipment Qualification, Sop Preparation, Change Control Management, Audit Documentation, Compliance, Cross-functional Coordination, Production, Engineering, Quality Control Microbiology, Quality Control Chemical, Risk Assessments, FMEA, QRM, Team Management, Data Integrity

Industry

Pharmaceutical Manufacturing

Description

Job Purpose To lead and manage validation activities for sterile injectable manufacturing operations, ensuring compliance with regulatory requirements (USFDA, EU GMP, WHO, MHRA, etc.), internal quality standards, and data integrity principles. Key Responsibilities 1. Validation Oversight * Review and approve Validation Master Plan (VMP). * Prepare, review, and approve protocols and reports for: * Equipment Qualification (DQ, IQ, OQ, PQ) * Process Validation (Media Fill, APS, PPQ) * Cleaning Validation * HVAC Validation * Water System Validation (PW/WFI) * Compressed Air / Nitrogen Validation * Computer System Validation (CSV) * Ensure lifecycle approach to validation as per regulatory expectations. 2. Sterile Injectable Compliance * Ensure validation activities comply with: * EU Annex 1 (Sterile Products) * USFDA guidelines * PIC/S, WHO requirements * Support aseptic process simulations and contamination control strategy (CCS). * Review environmental monitoring trends linked to validation activities. 3. Documentation & Data Integrity * Ensure ALCOA+ principles in all validation documentation. * Review and approve SOPs related to validation. * Maintain validation traceability matrix. * Ensure periodic review and requalification schedules are met. 4. Regulatory & Audit Readiness * Face regulatory audits (USFDA, MHRA, EMA, WHO). * Provide validation documentation during inspections. * Address audit observations (CAPA management). 5. Cross-Functional Coordination * Coordinate with: * Production * Engineering * QC Microbiology * QC Chemical * Projects Team * Provide validation input during new equipment procurement and facility modifications. 6. Risk Management * Conduct Risk Assessments (FMEA, QRM). * Ensure validation strategy aligns with product risk profile. * Review change controls impacting validated state. 7. Team Management * Supervise validation officers/executives. * Provide technical guidance and training. * Monitor team KPIs and ensure timely completion of validation activities. Skills : Process Validation (PV) for sterile injectable products - Proficient Equipment Qualification – IQ, OQ, PQ - Expert SOP preparation and review - Expert Change Control Management -expert Audit documentation & compliance - Expert Cross-functional coordination (Production, Engineering, QC) - Expert

Responsibilities

The Deputy Manager will lead and manage validation activities for sterile injectable manufacturing, ensuring strict compliance with global regulatory standards like USFDA and EU GMP, and upholding data integrity principles. Key duties involve overseeing the review and approval of validation documentation across equipment, process, cleaning, HVAC, and computer systems, while managing lifecycle validation approaches.