Assistant Manager - QA Microbiology ( 6 - 10 Years)
6 - 10 YearsBengaluru/Bangalore
Job Description
- Review & trending of analytical raw data from QC Microbiology on production and stability batches & associated, audit trails.
- Review of method validations & transfe;Technology transfer activities; Process capabality assessmen t.
- Review of instrument qualification& calibrations in QC Microbiology; Software compliance validations.
- Investigations for product failures; CAPA assessment & implimetation.
- Handling Quality management system documentation related to QC Microbiology.
- Conducting & facing audits (internal & External Customer.
- establishing S OP'S to maintain complaince levels in QC Microbiology.
- Vendor qualifications, handling raw material issues; non-routine qualification & validation ; training.
- Support activities towards DMF filing & regulatory queries.
- Risk assessment .
- Review of cell bank & fermetation process & characterization.
- water & environment monitoring & trending.
Company Profile
Biocon is an integrated biotechnology enterprise focused on the development of biopharmaceuticals. With successful initiatives in drug discovery and development, bioprocessing, manufacturing and global marketing, Biocon delivers products and solutions to partners and customers in over 75 countries. Biocon has the defining science, world class capabilities and a focused vision to deliver the promise of innovative and affordable medicine to a waiting world. Today, Biocon together with group companies employs more than 5000 employees with approxmimately Rs 2500 crore turnover and is expected to grow further during the current financial year .
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