Deputy Manager-QA

Key Roles/Responsibilities: To ensure cGMP in Quality Control laboratory. Review of QC / QA documents. Review and approve OOS, OOT, Incident, deviation and QC laboratory data and stability summary sheet. To prepare QMS (OOS, OOT, Lab Incident and Quality Event) Trends as per said procedure. To review and ensure effective implementation of regulatory requirement, guidelines and pharmacopeia changes like IP,BP,USP,Ph.Eur,JP etc. To review of QC laboratory records on periodic basis. To impart training to QC Laboratory personnel on SOPs, on-job training, regulatory requirements and guidelines. To ensure compliance of Qualification and calibration planner for QC instruments. To review QC Laboratory records (Issuance and archival of the documents like Laboratory note Book, Chromatograms, COA etc.). To provide Quest data on monthly basis to concern person. To perform self-audit of QC laboratory on periodic basis. To take the responsibilities of the activity in absence of immediate superior. To review audit trail for QC Instruments. To assign/disable password for QC Biometric system. Ensure compliance to KRA’s and other such assignments. Analytical and Electronic data review of respective batches at the time of release. Support to site DICO (Data Integrity Compliance Officer) for monitoring and implementation of actions related to Data Integrity awareness at site. Issuance and management of HPLC and GC column. Verification of admin audit trail along with IT person. To perform level-3 signoff for QC instruments wherever applicable.