Sr Executive- QC Analytical

Enzene Biosciences Ltd.; Pune District; On-site; INR 350,000 - 650,000; Full time

Job summary

Enzene Biosciences Ltd. in Pune is seeking a QC analyst to oversee analyst qualification and QC training, and to prepare and review critical documents including specifications, STPs, TDS, SOPs, COAs, MTPs, MVPs, MVRs and MTRs.

The role also covers review of analytical data for routine samples, method transfer and validation, and coordination for calibration of instruments. You will manage reference standards, calibration activities, equipment upkeep, and participate in method

Responsibilities

• Responsible for Analyst qualification & QC employee training.
• Responsible for Preparation and review of Documents like Specification, STPs, TDS, SOP, COA. MTP, MVP, MVR, MTR.
• Responsible for Review of analytical data for routine samples (in process samples, DS, DP release and stability samples) method transfer and method validation.
• Responsible for management of reference standard and material indenting in QC.
• Responsible for Co-ordination with vendor for external calibration and with QC personnel for in- house calibration and verification of laboratory instruments.
• Responsible for maintenance and management of laboratory equipment and instruments.
• Responsible for managing method validation and method transfer activities.
• Responsible for initiation and investigation of incident, deviations, change control, OOS, CAPA and OOT.
• Responsible for analysis planning of DS, DP, Stability and protocol-based samples.

Job description

1.Responsible for Analyst qualification & QC employee training.

2.Responsible for Preparation and review of Documents like Specification, STPs, TDS, SOP, COA. MTP, MVP, MVR, MTR.

3.Responsible for Review of analytical data for routine samples (in process samples, DS, DP release and stability samples) method transfer and method validation.

4.Responsible for management of reference standard and material indenting in QC.

5.Responsible for Co-ordination with vendor for external calibration and with QC personnel for in- house calibration and verification of laboratory instruments.

6.Responsible for maintenance and management of laboratory equipment and instruments.

7.Responsible for managing method validation and method transfer activities.

8.Responsible for initiation and investigation of incident, deviations, change control, OOS, CAPA and OOT.

9.Responsible for analysis planning of DS, DP, Stability and protocol-based samples.