How you’ll spend your day
Ensure on time dispatch related activity like verification of any deviation/OOS/LIR and other related QMS elements in the batch or its batch train.
Ensure Review of all documentation (i.e. batch records, test results, deviation, LIR, OOS, CAPA, validation, COA, Change Controls, etc.) and perform disposition (release/rejection) of batches.
Ensure review of executed document like batch record, analytical data etc. and to ensure on time compliance of error/deviations identified (if any).
Monitoring and follow-up of corrective and preventive actions (review, approval, and on time closure of the CAPA) in order to resolve an event.
Review and approval Process / documentation (i.e. Protocol/report) of reviewing effectiveness to determine the effectiveness of a corrective or preventive action.
Involving in investigation, Review, and ensuring on time closure of the investigation with resolution including corrective and preventive actions along with effectiveness determination.
Responsible for assuring / coordinating for timely shipment, delivery, and/or receipt to assure compliance with regulatory requirements.
Your experience and qualifications
Required B.Sc./ M.Sc. qualified candidate
3 to 4 years relevant experience
Hands on experience in batch disposition, Batch card review and Batch Release
Basic Knowledge about Deviation / OOS Investigation
Audit experience of USFDA / EDQM / EMA / TGA / PMDA. At least involved in any of the foreign regulatory Inspection
Experience in ERP, TrackWise & LIMS system
