Quality Assurance , Quality Control

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