Department Details

Role Summary

1. Adherence to cGMP (Current Good Manufacturing Practice) and cGLP (Current Good Laboratory Practice).

- Monitoring of laboratory environment (temperature, pressure, cleanliness, fumigation etc.)
- Analysis should be carried out in adherence to product specifications.
- Collection of samples for analysis and generation of analytical reference number.
- Testing of FP, stability, method validation and testing of materials and reporting of results for Bioassay methods.
- Review of analytical reports and review of usage logbooks, preparation of logbooks and Observation data sheets.
- Sample processing and aliquoting in Bioassay laboratory.
- Maintenance and subculturing of cell lines. Freezing and characterization of cells.
- Generation and maintenance of analytical records.
- Preparation of protocols and reports of Analytical method transfers and Analytical method validations.
- Verification of laboratory compliance, which includes validity checking of reagents, standards, system statuses.
- Equipment Qualification and temperature mapping.
- Ensuring effective implementation of EHS management system in the organization.
- Reporting and handling of QMS elements (incidents, change controls, deviations, OOT, OOS, CAPAs etc.).
- Preparation and revision of standard operating procedures, specifications and technical documents.
- Reserve sample storage for in process stages for different products.
- Training on documentation, methods pertaining to Bioanalytical laboratory and re-training as per the relevant schedule.

Secondary responsibility (Wherever Applicable)

- Receipt of in-process, DS, reserve sample and stability sample and storage at QC location.
- Calibration of analytical weighing balance and pH meter.
- Operation and calibration of analytical instruments.

Key Responsibilities

1.



Adherence to cGMP (Current Good Manufacturing Practice) and cGLP (Current Positive Laboratory Practice).
- Monitoring of laboratory environment (temperature, pressure, cleanliness, fumigation etc.)
- Analysis should be carried out in adherence to product specifications.
- Collection of samples for analysis and generation of analytical reference number.
- Testing of FP, stability, method validation and testing of materials and reporting of results for Bioassay methods.
- Review of analytical reports and review of usage logbooks, preparation of logbooks and Observation data sheets.
- Sample processing and aliquoting in Bioassay laboratory.
- Maintenance and subculturing of cell lines. Freezing and characterization of cells.
- Generation and maintenance of analytical records.
- Preparation of protocols and reports of Analytical method transfers and Analytical method validations.
- Verification of laboratory compliance, which includes validity checking of reagents, standards, system statuses.
- Equipment Qualification and temperature mapping.
- Ensuring effective implementation of EHS management system in the organization.
- Reporting and handling of QMS elements (incidents, change controls, deviations, OOT, OOS, CAPAs etc.).
- Preparation and revision of standard operating procedures, specifications and technical documents.
- Reserve sample storage for in process stages for different products.
- Training on documentation, methods pertaining to Bioanalytical laboratory and re-training as per the relevant schedule.

Secondary responsibility (Wherever Applicable)

- Receipt of in-process, DS, reserve sample and stability sample and storage at QC location.
- Calibration of analytical weighing balance and pH meter.
- Operation and calibration of analytical instruments.

Educational Qualifications

Required Education Qualification: M.Sc

Required Experience: 1 - 4 years

📌 Senior Executive (India)
🏢 BIOCON PHARMA
📍 India