Biocon Biologics Ltd
Designation : Asst Manager
Function : Quality Control
Functional Area : Biosimilars QC
Job Role Summary : Planning QC analysis, document review, Handle QMS documentation related to QC
Job Profile :
- Planning QC Analysis, Review of Analytical Documentation
- To handle QMS documents like Deviation, OOS, Change control, CAPA and Lab Incidents.
Raising, tracking, investigating and closing QMS elements (Change control, Deviation, OOS and Lab Incidents).
- Preparation of SOPs, Test Methods
- Trouble shooting of existing analytical methods
Job Requirements :
- Basic knowledge in chemistry and Biology.
- Good Knowledge on handling of LIMS software in Quality control (LIMS template creation, Sample Management Lot / Batch creation, Stability Management, Review and Approval Process in LIMS etc...)
- Knowledge on chromatography techniques (HPLC and GC) and other pharmaceutical Instruments.
- Knowledge on preparation of SPEC and Standard testing procedure. Review of Dossier, TTD and JOS.
Work / Job Experience : 8-12 Years
Type of Experience : Pharma QC experience, Handling QMS Documentation, Investigations, Deviations
Academic Qualifications :
- Master degree in any Chemistry / Biochemistry / Biotechnology/Life science.
