AGM - QA (Oral Solids)
Bioksha
- Location
- Gujarat, India
- Job type
- Full-time
About the role
Website:
bioksha.in
Job details:
Internal Job Description
- QMS : Identifying, handling and execution of Change Control, Deviation, OOS, OOT, Market Complaint, CAPA and Investigations.
- 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.
- 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.
- 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.
- Qualified Trainer : Involvement in the execution of training and development programme with respect to cGMP.
- TrackWise Digital Operation : To carry out activities in TrackWise as per the TrackWise Digital authorization.
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