About the role
Group Company: Enzene Bioscience Ltd
Designation: Senior Executive
Office Location: Pune, Chakan
Responsibilities:
- Completion of periodic classroom training/ online training as identified in Master Control Software.
- Analyst qualification for various assays within bioassay section
- Sample analysis for various DS, DP and Stability sample analysis.
- Participation in Method validation/ Method Transfer/ Method Qualification activities within bioassay section
- Participation in various Standard qualification/ Bio-similarity studies/ any other protocol-based studies.
- Maintenance of various cell lines, cell bank preparation.
- Adherence to ALCOA principles and Data Integrity policy.
- Timely compilation of TDS with adherence to Good Documentation Practices and submission for data review.
- Track availability of stock, consumables, reagents, Kits etc. required for QC Bioassay and timely preparation of monthly material indent requirement projection.
- Update records of material received from warehouse/ R&D in Bioassay.
- Performing lot registration, material issuance, material/ RMP reconciliation and requisite activities in Caliber LIMS software.
- Monthly capture physical inventory data in Bioassay and submit the data to supervisor.
- Adherence to Laboratory safety procedures.
- Daily monitoring of Humidity and Temperature.
- Immediate reporting and initiation of QMS element.
- Laboratory Maintenance for Anytime audit Readiness.
- Responsible for work assigned by immediate supervisor.
- Qualification of new entrants or new employee.
- Preparation of Quality Control Documents.
- Preparation of required reagents/ buffers/ media.
- Adherence to Quality Control defined procedures.
- Maintenance of reconciliation records.
- Providing reconciliation of issued documents from PCS to concerned personnel.
- Fulfil responsibilities as SPOC for reference standard management including tracking/ review/ stock verification of RMP/ IRS/ IPS.
- Fulfil responsibilities as SPOC for reference standard/ working standard module and chemical/ reagent module in CaliberLIMS.
- On time completion of document related workflows and creator/ initiator roles in Master Control Software and AQEM module.