Job Description

Responsibilities

Strategic & Planning:
- Ensure plant compliance with QMS as per defined guidelines.

Functional / Core:
- Review production schedules and verify compliance with product-specific requirements.
- Ensure timely and correct issuance of batch documents.
- Maintain traceability and reconciliation of all documents; review for non-compliance.
- Handle destruction of expired documents with proper record-keeping.
- Ensure all QA documents are fully completed.
- Implement the SIMPLOUD system effectively across departments.
- Support QA Manager during internal and external audits.
- Carry out self-inspections as per QA Manager's guidance.
- Collaborate with Engineering and Calibration teams for compliance.
- Handle customer complaints as per procedure.




- Monitor CAPA (Corrective and Preventive Actions).
- Maintain, prepare, and review monthly QMS reports.
- Perform batch release in the absence of the responsible person.
- Ensure continuity of documentation management in absence of key personnel.

Internal Processes:
- Ensure adherence to regulatory compliance.
- Maintain cGMP compliance throughout manufacturing.
- Comply with GMP and process audits.

People Development:
- Train management and plant associates on Valuable Documentation Practices (GDP).
- Provide training on compliance with data integrity and online documentation requirements.

📌 Lead -QMS (Aurangabad)
🏢 ACG
📍 Aurangabad