- Supervising all QC activities like microbiology, raw material analysis, environmental monitoring, instrumentation & wet biochemistry
- Responsible for all documentation work such as RM, IPQC, FP, stability samples, validation etc. Execution & Review of Instrument qualification (IQ, OQ & PQ).
- To plan, execute and monitor cell based assay development activity, ELISA, PCR and Compliance in the lab
- Final approval of COA for finished products, Water, Raw materials and packing material.
- Implementation of GLP in the QC Department
- Authorization of OOS & Deviations
- Review of documents related to SOP, STP, ATDS & validation process.
- A thorough understanding of Analytical method validations and method transfers: review of protocol and report.
- Conducting cGMP & GLP trainings in the departments.
- Communication with other departments such as QA, Production, Warehouse & R&D.
- Experience in handling instruments like HPLC, UV visible; Bioassay; CE-SDS and spectrophotometer etc.
- Should have worked on gel quantification, protein quantification, in process Quality Control activities.
- Should have thorough knowledge of all advanced analytical instruments & validation activities.
- Experience in cGMP/cGLP working environment.
- Experience in facing internal and external audits.
- Must be well versed with USP and EP guidelines and monographs pertaining to biotechnology derived products.
- Should possess a very good understanding of the GMP documentations involved both at the R&D (method transferring site) and the manufacturing site (method transferred site).
- Must possess good knowledge about regulatory guidelines pertaining to analytical methods development and validation in a GMP environment.
DATE & TIME: Will be intimated
VENUE: Biocon Campus, Bangalore
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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