QC - Bioassay

Enzene Biosciences Ltd; Maharashtra; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Enzene Bioscience Ltd in Pune/Chakan is seeking a Senior Executive for Bioassay operations. You will handle training, analyst qualification, and sample analyses for DS/DP and stability studies in a fast-paced bioassay lab.

You will contribute to method validation, transfers, and qualification activities, ensure ALCOA data integrity, maintain cell banks, and support QMS readiness with timely documentation.

Qualifications

• MSc/MPharma/MTech in related field or equivalent qualification.
• 6–9 years of experience in Pharma/Biopharma industry.
• Experience with bioassay operations and data integrity policies.

Responsibilities

• Complete periodic classroom/online training as identified in Master Control Software.
• Analyst qualification for assays in bioassay section.
• Sample analysis for DS/DP and Stability samples.
• Engage in method validation/ transfer/ qualification activities in bioassay.
• Participate in standard qualification/ bio-similarity studies and other protocols.
• Maintain cell lines and cell bank preparations.

Skills

Analyst qualification

Data integrity

GxP compliance

Laboratory safety

Documentation

Master Control Software

ALCOA principles

Caliber LIMS

AQEM module

SPOC responsibilities

Education

MSc in related field

MPharma

MTech

Tools

Caliber LIMS

Master Control Software

AQEM module

Job description

• 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.

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.

Education

MSc/ MPharma/ M Tech/ Masters in related field

Experience

6 to 9 years of experience in Pharma or Biopharma industry