Quality Assurance (QMS, IPQA and EQA) Specialist / Vizag

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.

2. 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.

3. 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.

4. 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.