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:
o Quality Plans
o Inspection & Test Plans (ITP)
o Standard Operating Procedures (SOPs)
o Test reports (FAT, IFAT, SAT)
o 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
Pay: ₹25,000.00 - ₹70,000.00 per month
Work Location: In person
