Biocon Biologics Limited
Designation : Asst Manager
Function : Biosimilars
Functional Area : Quality control
Job Role Summary : Manage laboratory analysis, stability programmes, review and approval of analytical documentation and reports, laboratory incident investigations
Job Profile :
- Raising, tracking, investigating and closing QMS elements (Change control, Deviation, OOS and Lab Incidents).
- Planning and designing of experiments, preparation of SOP's and Specifications.
- Handling LIMS software in Quality control (LIMS template creation, Sample
Management Lot / Batch creation, Stability Management, Review and Approval Process in LIMS etc...)
- Trouble shooting of existing analytical methods and highly skilled in chromatography techniques.
- Preparation of SPEC and Standard testing procedure. Review of Dossier, TTD and JOS.
- Handle QMS documents like Deviation, OOS, Change control, CAPA and Lab Incidents.
Job Requirements :
- Good Knowledge on handling of LIMS software in Quality controlÂ
- Knowledge on chromatography techniques (HPLC and GC) and other pharmaceutical Instruments.
- Knowledge on cGMP and GLP practices.
- Basic knowledge in chemistry and Biology.
Work / Job Experience : 8-12 Years
Type of Experience : Pharma Quality control experience in Biosimilars, Biologics, LIMS experience
Academic Qualifications :
- Master degree in any Chemistry / Biochemistry / Biotechnology/Life science.
