Senior Executive

Enzene Biosciences Ltd.; Pune District; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Darwinbox Digital Solutions Pvt. Ltd. in Pune is seeking a seasoned QA Analyst for pharma/biopharma QC.

You will complete periodic training, maintain bioassay records, and ensure data integrity per ALCOA principles using Master Control Software and Caliber LIMS. The candidate will perform sample analysis, participate in method validation/transfer/qualification, keep QC documents updated, manage reference standards, and ensure audit readiness with timely reporting and material inventory control.

Qualifications

• 6–9 years of pharma or biopharma QA experience.
• Experience in bioassay QC and related data integrity practices.
• Proficient with GMP/GxP documentation and QC workflows.
• Hands-on with LIMS and QC data systems.
• Knowledge of ALCOA principles and QMS.

Responsibilities

• Perform sample analysis and data entry for DS/DP/stability.
• Participate in method validation, transfer, and qualification activities.
• Prepare and maintain QC documents and reagents.
• Ensure document workflows in Master Control Software.
• Maintain lab equipment and ensure audit readiness.

Skills

Bioassay QC

GxP Compliance

Data Integrity

Caliber LIMS

Master Control Software

Education

MSc/MPharma/M Tech

Tools

Master Control Software

Caliber LIMS

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.

Education: MSc/ MPharma/ M Tech/ Masters in related field

Experience: 6 to 9 years of experience in Pharma or Biopharma industry