Internal

A) QMS : Identifying, handling and execution of Change Control, Deviation, OOS, OOT, Market Complaint, CAPA and Investigations.

B) General-QA

- Partake in controlling, implementing, executing, Identifying, review, approval and handling of Change Control, Deviation, Market Complaints, CAPA and Investigations.
- Partake in controlling, implementing, executing the activities of QA.
- To check the compliance and execution of SOP's.
- Online maintenance of documents and Maintenance of documentation cell.
- Preparation, review and approval of SOP's.
- Review of Quality Risk Management Report and coordination in Quality Risk Management activity.
- Handling of desctruction and disposal documents.
- Handling of online rejection documents.

C) Audit Compliance, TWD Audit Management:

- Handling of GMP Audit by Customer and coordination of compliance response to Regulatory observations.
- Handling of Internal and External Audits.




- Tracking for Implementation and closure of identified CAPA.
- Implementation and verification of Global CAPA at Site.

D) Complaint and Recall, Review of Investigation

- To aid in the investigation of customer complaints as well as the implementation of the suggested preventive actions.
- Prepare and Review the customer complaint investigation report.
- Involve in the investigation of recall and returned products activity of drug product.
- Preparation of Mock recall protocol and Mock recall Report.
- Preparation & review of FAR.

E) Qualified Trainer : Involvement in the execution of training and development programme with respect to cGMP.

F) TrackWise Digital Operation : To carry out activities in TrackWise as per the TrackWise Digital authorization.

📌 AGM - QA (Oral Solids) (Diu)
🏢 USV
📍 Diu