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 recent 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.

Education:
MSc/ MPharma/ M Tech/ Masters in related fieldExperience: 6 to 9 years of experience in Pharma or Biopharma industry

📌 QMS & Compliance (Pune)
🏢 Enzene Biosciences
📍 Pune