- Handling Customer Complaints. Response to customers, monthly summary.

- Follow up with Sales/ Customers for timely closure of complaints. Credit note justification.

- Review of production schedule and their compliance to the specific requirements & CAPA during product manufacturing.

- MIS Reports Monthly reports of QA Department, IQC, Dimension Summary.

- Compilation of dimension summary reports of all locations.

- Batch Management Records 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.

- manner for easy and quick retrieval.

- Ensure proper storage of all the Batch manufacturing record in a systematic

- 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 carrying 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.

- Arranging for Health Certificates, AQCS Certificates for Exports consignments





Qualification & Validation

- Prepare Validation master plan annually and ensure adherence to schedule for

qualification and validation of equipment/instrument, area etc.

- Prepare and approve the protocol which need to be executed before the Validation is initiated.

- Participate in validation and qualification as per the approved protocol.

- Work with the used department in listing down the observation as per the approved protocol.

- The conclusion drawn from the Validation / Qualification to be shared with the QA/Quality Head.

- Working with the Engineering Team / Calibration team with compliance with GEFU

- Support the DMS system implementation across the plant.

Authorities

- Authorised for Final release of Finished product batches

- To raise QMS documents like Change control, deviation, OOS, Investigations etc.

- Authorised to raise Purchase Requisitions

- Authorised to communicate with customers for complaint handling.

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 Valuable Documentation Practices (GDP)

- Training on compliance to Data Integrity.

Training on the requirement of online documentation.

📌 Senior Officer Dahanu Quality, ACG Capsules (India)
🏢 Important Group
📍 India