Key Responsibilities

1. Engineering QA

- Provide QA oversight for engineering, utilities, facilities, HVAC, water systems and critical GMP equipment.

- Review/approve URS, DQ, FAT/SAT, IQ, OQ, PQ and requalification documents.

- Review engineering-related Change Controls, Deviations, Investigations, CAPA and Risk Assessments.

- Ensure critical equipment and utilities remain in a qualified and compliant state.

- Review GMP impact of engineering modifications, maintenance and breakdowns.

- Support regulatory and customer audits related to Engineering and Utilities.

1. Quality Management System

- Manage and monitor key QMS elements including:

- Deviation Management

- CAPA

- Change Control

- Quality Risk Management

- Document Management
- Internal Audits / Self-Inspection

- Management Review

- Quality Metrics and Trending

- Periodic Review

- Inspection Readiness
- Review investigation reports and ensure appropriate root-cause analysis and effective CAPA.

- Monitor QMS timelines and ensure timely closure of actions.

- Identify recurring/systemic issues through trend analysis and drive continuous improvement.

- Ensure QMS procedures remain aligned with current GMP and regulatory expectations.

1. Training Management





- Manage the site's GMP Training System in coordination with QA and functional departments.

- Prepare and monitor the annual training calendar.

- Ensure timely completion of GMP, SOP, functional, OJT and compliance training.

- Review/approve training materials, including PPTs, OJT materials and learning capsules.

- Establish appropriate training content governance, version control and approval mechanisms.

- Ensure training effectiveness is evaluated where required.

- Monitor training compliance, overdue training and training metrics.

- Identify training gaps based on deviations, CAPA, audits, regulatory observations and QMS trends.

- Develop targeted GMP learning programs based on inspection and quality intelligence.

1. Audit & Inspection Readiness

- Support and coordinate IPQA activities for USFDA, EU, PIC/S, WHO, customer and other regulatory audits.

- Ensure Engineering, QMS and Training systems remain inspection-ready.

- Coordinate remediation of audit observations and track CAPA commitments.

- Ensure lessons learned from audits and regulatory observations are appropriately incorporated into the QMS and training system.

📌 Quality Assurance (QMS, IPQA and EQA) Specialist / Vizag (Visakhapatnam)
🏢 Metrochem
📍 Visakhapatnam