Shilpa Biologicals Pvt. Ltd – Hiring QC Analytical – Apply Now
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
- Fair understanding on Data integrity, ALCOA principles, ICH guidelines, 21 CFR Part 11 expectations, GAMP and CSV (Computer system validations).
- Working in QC set up preferably from biologics (monoclonal antibodies and therapeutic proteins, Vaccine) industry.
- Planning and performing In-Process, Finished product (DS) and stability sample testing of Monoclonal antibodies using PCR, QPCR, mycoplasma detection by PCR, ELISA methods.
- 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.
- Good understanding on method transfer and method validations as per ICH guidelines.
- Routine mammalian cells subculturing, and media preparation.
- Cell bank (WCB and MCB) preparation, and qualification
- Conducting cell based bioassays for estimation of potency of finished products.
- Review of analytical reports of Inprocess, Finished product, stability, method validation, method transfer and study,
- Review of usage log books, preparation log books and Observation data sheets.
- Preparation and review of method validation, method transfer, study protocol and reports.
- Testing of method transfer, method validation and study samples.
- Verification of laboratory compliances, which include the validity checking of the reagents, standards, system status etc.
- Reporting and investigation of Incidents, OOS, OOT and Deviation.
- Receipt of inprocess, DS, reserve samples and stability samples and storage at QC location.
- Qualification of Analytical instruments (IQ/OQ/PQ).
- Operation and calibration of analytical instruments.
Interested candidates can share your CV to below mail Id:
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