Team Leader - LAB QA (Sterile/Injectable)

Role & responsibilities

1. Proficient in laboratory activities are in compliance with current company policies, procedures and cGMP/cGLP requirement.
2. Online Review of Microbiological results, having adequate knowledge in BET, sterility, Environmental monitoring, MLT, Bioburden Etc.
3. Proficient in preparation of and Review of Alert and action level Evaluation.
4. Review of Instrument/Equipments Qualification Documents.
5. To be part of the investigation team for all types of non-conformances (OOS, OOT, OOAC, OOAL, Deviation, CAPA, Incidences/INV) & Closure of OOS/OOT/OOAC/OOAL/ Incidences/INV/Deviation and CAPA in respective software log.
6. Ensuring the investigation process appropriately followed for the non-conformances (OOS/OOT/OOAC/OOAL/incidences/INV and Deviation) test results as per procedure specified in respective SOPs and verifying the impact of the incidence on current as well as previous material/product quality.
7. Preparation of Water trends as per schedule.
8. To perform software review and Audit trail review of all the instruments available in Quality Control & Microbiology Department as per schedule.
9. Handling Trackwise, LIMS and SAP are added advantage.