Key Responsibilities
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.
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.
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.
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