Senior Officer Dahanu Quality, ACG Capsules

• 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 Good Documentation Practices (GDP)


• Training on compliance to Data Integrity.

Training on the requirement of online documentation.