ASSOCIATE MANAGER

Department Details

Role Summary

Primary responsibilities :

1) To ensure Implementation of Data Integrity Culture in Quality Control Lab.

2) Adherence to cGMP (Current Good Manufacturing Practice), cGLP (Current Good Laboratory Practice) and GDP (Good Documentation Practice) and ensure all time audit readiness in the lab.

3) Qualification of Analytical instruments and Equipment (IQ / OQ / PQ) and Facility readiness.

4) Receipt of in process, DS, reserve samples and stability samples and storage at QC location.

5) Planning and performing In-Process, finished product (DS) and stability sample testing of Monoclonal antibodies and reporting the results. Enter batch result in SAP.

6) Review and Management of Stability studies as per approved procedures.

7) Review of analytical reports of In-process, finished product, stability, method validation, method transfer and study, Review of usage logbooks and Observation data sheets.

8) Preparation and review of method validation, method transfer, study protocol, Stability protocols and summary sheet (Compilation Data) and reports. Method transfer within BBL locations / external partners / QP labs / External testing labs.

9) Review and tracking of method transfer documents / new product introduction documents and perform trouble shooting, as and when required, to ensure timely completion, as per project timelines / business deliverables.

10) Verification of laboratory compliances, which include the validity checking of the reagents, standards, system status etc.

11) Reporting and investigation of Incidents, OOS, OOT and Deviation / QMS documents along with root cause analysis, CAPA implementation and effectiveness monitoring.

12) Supporting Operational Excellence, 5S in Quality control Lab.

13) Calibration / Verification of analytical instruments as per approved procedures and frequency.

14) Review of EMS results / reports; review / verification of temperature data / alarm logs / reports of stability chambers.

Secondary responsibilities :

1) Cross functional coordination with all the inter departments for smooth flow of activities.

2) Supporting other QC functions when required.

Key Responsibilities

Primary responsibilities :

1) To ensure Implementation of Data Integrity Culture in Quality Control Lab.

2) Adherence to cGMP (Current Good Manufacturing Practice), cGLP (Current Good Laboratory Practice) and GDP (Good Documentation Practice) and ensure all time audit readiness in the lab.

3) Qualification of Analytical instruments and Equipment (IQ / OQ / PQ) and Facility readiness.

4) Receipt of in process, DS, reserve samples and stability samples and storage at QC location.

5) Planning and performing In-Process, finished product (DS) and stability sample testing of Monoclonal antibodies and reporting the results. Enter batch result in SAP.

6) Review and Management of Stability studies as per approved procedures.

7) Review of analytical reports of In-process, finished product, stability, method validation, method transfer and study, Review of usage logbooks and Observation data sheets.

8) Preparation and review of method validation, method transfer, study protocol, Stability protocols and summary sheet (Compilation Data) and reports. Method transfer within BBL locations / external partners / QP labs / External testing labs.

9) Review and tracking of method transfer documents / new product introduction documents and perform trouble shooting, as and when required, to ensure timely completion, as per project timelines / business deliverables.

10) Verification of laboratory compliances, which include the validity checking of the reagents, standards, system status etc.

11) Reporting and investigation of Incidents, OOS, OOT and Deviation / QMS documents along with root cause analysis, CAPA implementation and effectiveness monitoring.

12) Supporting Operational Excellence, 5S in Quality control Lab.

13) Calibration / Verification of analytical instruments as per approved procedures and frequency.

14) Review of EMS results / reports; review / verification of temperature data / alarm logs / reports of stability chambers.

Secondary responsibilities :

1) Cross functional coordination with all the inter departments for smooth flow of activities.

2) Supporting other QC functions when required.

Educational Qualifications

Required Education Qualification : Msc

Required Experience : 11 - 15 years