Shilpa Biologicals Pvt. Ltd. – Biopharma started its operations in 1987 at Raichur, Karnataka- India. The 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.
Greetings for the day..!
Hiring for QC Analytical
- Experience – 1 – 5 years
- CTC: 3Lakh-4Lakh
- Note: Only Male Candidates can apply
Job Responsibilities:
1. Fair understanding on Data integrity, ALCOA principles, ICH guidelines, 21 CFR Part 11 expectations, GAMP and CSV (Computer system validations).
2. Working in QC set up preferably from biologics (monoclonal antibodies and therapeutic proteins, Vaccine) industry.
3. Planning and performing In-Process, Finished product (DS) and stability sample testing of Monoclonal antibodies using PCR, QPCR, mycoplasma detection by PCR, ELISA methods.
4. Technical proficiency on Bioanalytical methods/Biochemical methods/Molecular biology methods such as HCDNA, SDS PAGE, Western blot, IEF, Identity ELISA, HCP ELISA, LPA ELISA and Cell based proliferation, inhibition of proliferation, binding assays etc.
5. Good understanding on method transfer and method validations as per ICH guidelines.
6. Routine mammalian cells subculturing, and media preparation.
7. Cell bank (WCB and MCB) preparation, and qualification
8. Conducting cell based bioassays for estimation of potency of finished products.
9. Review of analytical reports of Inprocess, Finished product, stability, method validation, method transfer and study,
10. Review of usage log books, preparation log books and Observation data sheets.
11. Preparation and review of method validation, method transfer, study protocol and reports.
12. Testing of method transfer, method validation and study samples.
13. Verification of laboratory compliances, which include the validity checking of the reagents, standards, system status etc.
14. Reporting and investigation of Incidents, OOS, OOT and Deviation.
15. Receipt of inprocess, DS, reserve samples and stability samples and storage at QC location.
16. Qualification of Analytical instruments (IQ/OQ/PQ).
17. Operation and calibration of analytical instruments.
Interested candidates can share your CV to below mail Id:
hrd_bio@shilpabio.com, / asasidharan@shilpabio.com
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