Biocon Pharma Ltd
Designation : Deputy Manager
Function : Quality Control
Functional Area : QC Generic Formulations
Job Role Summary : Team Lead – Commercial Finished & Stability, Sample Management and planning, document review, audit trail review, QMS documentation
Job Profile :
- Responsible to review the analytical activity/data adherence to comply with ALCOA++ in the Log books/Formats/observation data sheet along with print outs attached, countersigned, secured in proper folders. Ensuring the analyst handed over the ODS along with all the raw data at the end of the day.
- Responsible for review of Audit trails and raw data generated by instruments in quality control on the same day of processing / reporting.
- Responsible for the creation of different projects, methods and updating the configurations for the chromatographic systems and other software systems.
- Responsible for the online review and locking of chromatographic sequences in the system against sequences prepared. verification on daily basis, periodic calibrations, preventive maintenance and qualification of instruments. Responsible to ensure there is no sequence errors due to review oversight.
- Responsible to ensure that the analysts are having dedicated clean trays, pipette stand, dessicator, waste disposal bin for analysis and glassware labelling done legibly during the analysis. Responsible to ensure the retention of glassware till the review of documents.
- Ensure the cleanliness of the instruments and ensuring the updation of instrument status board and to ensure that the daily calibrations are reviewed promptly and released for routine usage. Responsible to release the instruments for further analysis only after review completion.
- Responsible for the preparation, review of Specifications, STP's, ODS, COA's and preparation, review and implementation of quality control SOP's and IOP's.
- Responsible to actively participate in laboratory investigation of the OOS/OOT, incidents and deviations observed in Quality control lab. Responsible for reduction in human error to avoid the recurrence of OOS, incidents and deviations.
- Responsible for timely closure and supervise the change controls, deviations and implementation of CAPA raised due to out of specifications, incidents, deviations or from any other source in Quality Control lab.
- Responsible for active participation in the Regulatory audits, external and internal audits of Quality Control.
- Responsible for stability study of drug products, sample management, review of stability Protocols, review of stability studies data and grid preparations. Responsible to ensure charging and pull-out of stability samples in stability chambers as per schedule.
- Responsible to ensure maintenance of stability chambers which covers cleaning, monitoring of temperature and humidity, review of Testo software daily data and review of Nova LIMS stability protocols/ results/etc.
Job Requirements :
- Experience: 12 to 14 years
- Pharma formulations QC - Commercial samples, stability programme, QMS, Change controls, incident investigations
Work / Job Experience : 12-14 Years
Type of Experience : Pharma QC Finished products, Raw Materials Analysis, Analytical Compliance
Academic Qualifications :
- M Pharma / MSc (Chemistry)
