Officer
IRF - Aurangabad, MH, IN
Job Description
- Preparation of the standard operating procedures and perform activities and task as per the SOPs.
- Execution of new products from LRP and site transfer products from other location to Aurangabad plant (Scale up, exhibit, process performance qualification/validation and commercial batches).
- Troubleshooting during production runs.
- Preparation of batch manufacturing records for trial, scale up, exhibit, process performance qualification/Validation and Commercial batches.Preparation of scale up sampling plan/report for scale up batch.
- Preparation of process performance qualification/validation protocols and reports for exhibit, qualification/validation and Commercial batches.
- Preparation and review of Stability Study protocol for trial, exhibit (only in case of site transfer products), process performance qualification/validation and commercial batches.
- Initiation and closure of respective QAMS activities.
- Perform Quality risk management (QRM) for exhibit and commercial products.
- Preparation and review of BOM / Recipe / FG / SFG code creation, Potency formula updation in SAP and co-ordination with SAP masters team.
Work Experience
2-5 years
Education
Competencies