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.

1. Documentation Accuracy &
- Control

Maintain accurate, complete, and controlled documentation.

1. Inspection &
- Testing Effectiveness

Ensure effective inspection and testing activities

1. Non-Conformance &
- CAPA Management

Effective handling and closure of non-conformances.

1. Audit &
- Validation Support

Support internal, customer, and regulatory audits

1. Cross-Functional &
- Customer Coordination

Effective coordination with internal teams and customers.

1. Change Management &
- Traceability

Ensure controlled implementation of changes.

1. Continuous Improvement &
- Training

Support quality improvement initiatives

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