QA-Executive - Assistant Manager (QMS, IPQA, Validation & CSV)

NA; Hyderabad; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

NA Hyderabad-based pharmaceutical quality role seeks experienced validation professional to execute and review process validation, cleaning validation, and equipment qualification (DQ, IQ, OQ, PQ) while maintaining compliance with cGMP and data integrity.

Responsibilities include preparing validation documents, participating in audits, and supporting technology transfer for new products with cross-functional teams across Production, Engineering and Regulatory Affairs.

Qualifications

• Experience in Injectable, Sterile, Vaccine or Biologics manufacturing.
• Strong knowledge of regulatory guidelines including USFDA, EU GMP, WHO, MHRA and PIC/S.
• Good communication and documentation skills.

Responsibilities

• Execute and review process validation, cleaning validation, equipment qualification (DQ, IQ, OQ, PQ) and hold time studies.
• Prepare, review and approve validation protocols, reports and SOPs.
• Handle QMS activities including Deviations, CAPA, Change Control, OOS, OOT, Risk Assessment and investigations.
• Perform IPQA activities during manufacturing, filling, packaging and aseptic operations.
• Ensure compliance with cGMP, GLP, GDP, Data Integrity and regulatory requirements.
• Manage CSV documentation and lifecycle activities as per GAMP 5 and 21 CFR Part 11.
• Review BMR, BPR and validation documents.
• Participate in internal audits, regulatory inspections and customer audits.
• Support technology transfer, qualification and validation for new products and equipment.
• Coordinate with Production, Engineering, QC and Regulatory Affairs for quality compliance.

Skills

Process validation

IQ/OQ/PQ

QA documentation

GAMP 5

Job description

Role & responsibilities

• Execute and review process validation, cleaning validation, equipment qualification (DQ, IQ, OQ, PQ) and hold time studies.
• Prepare, review and approve validation protocols, reports and SOPs.
• Handle Quality Management System (QMS) activities including Deviations, CAPA, Change Control, OOS, OOT, Risk Assessment and investigations.
• Perform In-Process Quality Assurance (IPQA) activities during manufacturing, filling, packaging and aseptic operations.
• Ensure compliance with cGMP, GLP, GDP, Data Integrity and regulatory requirements.
• Manage Computer System Validation (CSV) documentation and lifecycle activities as per GAMP 5 and 21 CFR Part 11.
• Review Batch Manufacturing Records (BMR), Batch Packing Records (BPR) and validation documents.
• Participate in internal audits, regulatory inspections and customer audits.
• Support technology transfer, qualification and validation activities for new products and equipment.
• Coordinate with Production, Engineering, QC and Regulatory Affairs for quality compliance.

Preferred candidate profile

• Experience in Injectable, Sterile, Vaccine or Biologics manufacturing.
• Strong knowledge of regulatory guidelines including USFDA, EU GMP, WHO, MHRA and PIC/S.
• Good communication and documentation skills.