Intas Pharmaceuticals - Quality Assurance Role

- To monitor line clearance, sampling activities in manufacturing and packing (General Parenteral, External preparation, Depot & Oncology division) area in accordance with the approved SOPs.

- To ensure cleaning, sanitization, sterilization activities and aseptic practices at the production floor as per approved SOPs.

- To ensure the compliance of the operations in General Parenteral, External preparation, Depot & Oncology division in accordance with respective approved SOPs and cGMP requirements. 

- To ensure the equipment used are within the due course of qualification status. 

- Review and approval of the Change Controls, investigations, Deviations and CAPAs pertaining to parenteral (General Parenteral, External preparation, Depot & Oncology)

- Review and approve the investigations of OOS / OOT / OOC / Market Complaints as per requirement.

- Preparation, review, approval and authorise SOPs.

- Participation in self inspection programme, internal and external audits.

- Review and approval of the Qualification / Validation Protocols & Reports, Stability reports, APQRs, MPCR and other cGMP records. 

- Conducting technical training programmes on cGMP, on job training etc.

- Responsible for final release of the batches pertaining to General Parenteral, External preparation, Depot & Oncology division.

- To perform various SAP/LIMS transactions.

- Co-ordination with RA and third parties. 

- To assist Associate Vice President - Q. A./equivalent designee and report them, if any discrepancy / deviation found during production activities.

- Coordinating activity related to regulatory and customer audit compliance.