Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations.
Job Title – IPQA – Injectables
No.of.Posts – 7
Experience – 3-7 years.
Location – Visakhapatnam/Vizag
UG -B.Pharma – Pharmacy
PG – M.Pharma – Pharmacy
- Responsible to carry out and perform the line clearance, material verification, start-up checks and in-process checks as per the Batch manufacturing and Batch packing records.
- Responsible to carry out timely sampling of In-process samples/ reserve samples/ stability samples.
- Reserve sample collection, maintenance and inspection and destruction of expired samples.
- Review of batch manufacturing and batch packing records and certification of the same after execution.
- Review of status of on line activity and its labelling in warehouse / production / engineering and utility areas.
- Coordination in cleaning validation, carry out sampling and compliance.
- Monitoring of personal hygiene of production shop floor personnel.
- Ensuring good documentation practices.
- Implementation and compliance of Technology Transfer and initiation of exhibit batches.
- Coordination in sampling, dispensing activities and return of dispensed/unused materials to warehouse.
- Handling of building and facility maintenance plan.
- Review and approval of break down issues.
- Responsible to carry out the Pack Stock Check and to report the observations.
- Responsible for monitoring of projects like facility/ equipment after initiation of the technology transfer at the proposed manufacturing location.
- Responsible for clearance of facility, equipment usage for the next product after verifying the Cleaning verification Data.
- Issuance of Record of Analysis/Analysis Reports/Batch Manufacturing Records as per requirement and SOPs
- Issuance of user copies, retrieval of old user copies & its destruction & maintenance of all Master documentation.
- Issuance of artworks and in-house labels for Production.
- Ensure necessary changes in Master documents through change controls.
- Issuance and review of log books from the Cross Functional Departments.
- Review of validation protocols and Reports.
- Review and investigations of shop floor investigations through SAP.
- Ensuring shop floor compliance.
- Participation and ensuring compliance during execution of process simulation studies.
- Review of alarm reports audit trial reports and access control reports.