About Shilpa Biologicals Private Limited:
Shilpa Medicare Limited (SML) started its operations as an API manufacturer way back in 1987 in Raichur, Karnataka- India. Commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.
Shilpa Medicare has been on a path of expansion ever since its inception in 1987. With a regulatory-recognized manufacturing set-up and an excellent scientific expert team in place, Shilpa Medicare has since been on a steady growth path.
Currently, we are one of the leaders in the Oncology market and offer a complete range of products in this segment spanning APIs, and formulations both in terms of R&D and manufacturing capabilities. Further to consolidation in the field of oncology API and formulations, we are striving to put in our efforts in the field of novel drug delivery systems and biotech products along with widening our focus to other therapy areas. Where we are today has been the result of our constant endeavours for more than two decades. We are proud to share our journey from being a small start-up to a well-recognized establishment …
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About Shilpa Biologicals Private Limited Jobs:
We Shilpa biologics hiring for the department of- Quality Assurance.
Experience: 10-15 years
Educational Qualification: M.Sc/B.Sc Biotechnology, M.Tech/B.Tech, M.Pharma/B.Pharma.
Designation: Assistant manager – Manager
Job Location: Dharwad, Karnataka.
1. Responsible for Monitoring of cGMP practices at shop floor and to certify line clearance during various processing stages.
2. Responsible for IPQA activities/process Monitoring & Performing in-process checks during at various manufacturing stages
3. Responsible for Preparation, planning and execution, review, compilation, and approval of SLIA, URS, QRA, Design qualification, FAT/SAT, Installation Qualification, Operational Qualification (OQ) and Performance Qualification (PQ) protocols and reports for process equipment, utilities, and laboratory instruments.
4. Responsible for Execution, Review, Compilation & approval of periodic requalification, re-qualification after modification.
5. Responsible for Preparation, review and approval of cleaning and process validation protocol and reports.
6. Responsible preparation and approval of Technology transfer plan/protocol and ensuring the requirements of pre-checklist and post checklist of Technology transfer fulfilled.
7. Responsible for review, evaluation and approval of Change controls, Deviations, tracking for closure within the timeline and Excursions which are occurred during manufacturing process and process equipment’s
8. Responsible review of Shut down and restart procedure for facility and equipment and review and approval of maintenance service request and assessment of the activity performed by team.
9. Responsible to ensure safety procedures and usage of proper PPEs in the facility as applicable and Management of cGMP/GDP training at site.
10. Responsible for Monitoring of cGMP practices at shop floor and to certify line Preparation clearance during various processing stages.
11. Support to internal /External audits.
12. Training to team members on GMP and SOP’s
13. Responsible for Handling and Management of Cell bank.
14. Responsible for review and approval of Executed Batch manufacturing records.
Interested candidates can share your CV to [email protected]
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FAQ Related To Shilpa Biologicals Private Limited:
Q. Which is the official website of Shilpa Biologicals Private Limited?
Q. What is the address of Shilpa Biologicals Private Limited?
Ans: Plot 532/A, Belur Industrial Area, Dharwad-580011 Karnataka INDIA.