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Supervisor - QA- Documentation & Validation, ACG Capsules (Quality)

4 months ago

Pithampur, India ACG Full time

/Primary Responsibilities/g

To ensure the Plant complies to the QMS system as per the laid down guidelines.
Functional
Core
• Review of production schedule and their compliance to the specific requirements in the manufacturing of products.
• Ensure correct and timely issuance of batch documents.
• Review the completed batch documents and ensure compliance to the manufacturing process before the batch is released.
• Ensure timely review and release of batch manufacturing record as per GDP.
• Ensure traceability and reconciliation of All documents and review the same for non-compliance.
• Ensure proper storage of all the Batch manufacturing record in a systematic manner for easy and quick retrieval.
• Destruction of documents after its expiry period with proper record.

• Ensure all the Quality Assurance documents are filled completely.
• To ensure effective implementation of DMS system in all departments.
• Support to QA Manager during the internal and external audits.
• Support to QA manager by carry out self-inspection / CTQ audits
• To carry out inspection of Transit vehicle.
• Working with the Engineering Team / Calibration team with compliance with GEFU
• Handling of DMS system.

Internal process
• Adherence to Regulatory Compliance,
• Compliance to GMP Audit/Process Audit,
• BMR review and Batch Release to meet regulatory requirements,
• Ensure c-GMP compliance during the entire manufacturing process.

People development
• Training Management associate on Good Documentation Practices (GDP)
• Training Plant associates on Good Documentation Practices (GDP)
• Training on compliance to Data Integrity.
• Training on the requirement of Online documentation.