Responsibility

- Establish, implement, and maintain Quality Assurance and Quality Control systems in line with ISO, GMP, customer specifications, and internal quality standards.
- Review and verify engineering, automation, and electrical documentation (P&ID;, GA drawings, wiring diagrams, PLC FDS, test protocols) for compliance and completeness.
- Ensure effective document control, including creation, review, approval, version control, distribution, and archival of quality documents.
- Prepare, review, and manage QA/QC documentation such as:
- Quality Plans
- Inspection & Test Plans (ITP)
- Standard Operating Procedures (SOPs)
- Test reports (FAT, IFAT, SAT)
- Non-Conformance Reports (NCR) and CAPA records
- Conduct in-process inspections and final quality inspections of panels, software, and assembled systems to ensure adherence to approved drawings and specifications.
- Monitor and ensure compliance during FAT / IFAT / SAT activities, validating process flow, interlocks, alarms, and safety requirements.
- Identify, document, and track non-conformities, ensuring timely root cause analysis and effective Corrective & Preventive Actions (CAPA).
- Coordinate with engineering, PLC, electrical, and production teams to resolve quality issues and implement improvements.
- Support internal, customer, and regulatory audits, ensuring timely closure of observations with proper documentation.
- Ensure traceability of materials, components, software versions, and test records throughout the project lifecycle.




- Maintain and update quality dashboards and reports to track compliance, NCR trends, and audit readiness.
- Coordinate with customers and cross-functional teams to ensure timely submission and approval of quality and project documentation.
- Support change management, ensuring all design, logic, or process changes are properly documented and approved.
- Promote continuous improvement initiatives to reduce rework, deviations, and documentation errors.
- Train and guide internal teams on quality procedures, documentation practices, and compliance requirements.
- Ensure all documentation aligns with pharmaceutical validation requirements and customer expectations.

KRA

1. Quality Compliance & Standards Adherence

Ensure compliance with GMP, ISO, and customer quality requirements.

2. Documentation Accuracy & Control

Maintain accurate, complete, and controlled documentation.

3. Inspection & Testing Effectiveness

Ensure effective inspection and testing activities

4. Non-Conformance & CAPA Management

Effective handling and closure of non-conformances.

5. Audit & Validation Support

Support internal, customer, and regulatory audits

6. Cross-Functional & Customer Coordination

Effective coordination with internal teams and customers.

7. Change Management & Traceability

Ensure controlled implementation of changes.

8. Continuous Improvement & Training

Support quality improvement initiatives

📌 Quality Assurance Manager (Mumbai)
🏢 Qelvo Workforce
📍 Mumbai