Biocon is a research-driven, global healthcare company with a strong matrix of capabilities along the biopharmaceutical value chain. Focusing on unmet medical needs in cancer, diabetes and inflammatory diseases, it offers novel therapies on a platform of affordable innovation.
Biocon together with group companies employs more than 2500 employees with approxmimately Rs 1,000 crore turnover and is expected to grow further during the current financial year.
Post: Asst Manager - Quality Assurance - HC/JC/1892/12
Job Description:
Job purpose:
· To manage a team of 9 people ( Mol Bio & Biological commercial products)
· To plan, execute and monitor the release of commercial products
· Addressing customer complaints and regulatory agencies comments on product quality
· Planning and execution of method qualification, transfer and validation
· To manage day to day operation of Mol Bio unit
· Facilitating yearly budget and recruitment proposal for Mol Bio unit and
· Addressing deviations, OOS and OOT
Required skill set:
1. A thorough understanding and hands on experience on Mol Bio related techniques such as PCR, RT PCR, ELISA and cloning.
2. A thorough understanding and relevant hands on experience on estimating process related impurities such as host cell DNA and protein.
3. Previous experience in handling potency assays ( non-cell based assays)
4. A thorough understanding of method transfer, qualification and validation
5. Experience in working cGMP working environment , facing internal and external audits
6. Experience in equipment calibration, qualification and maintenance of log books entry & exit procedur.
Additional Information:
Experience: 4-6 Years
Location: Bangalore
Education: M.Sc, M.Tech, PH.D
Industry Type: Pharma/Biotech/Clinical Research
Functional Area: QA
End Date: 20th Nov, 2012
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