Validation Specialist
Sai Life Sciences Ltd
Total years of experience :1 years, 8 Months
● Assisting in investigations, like Out of specification/Out of trend (OOS/OOT) results, Deviations, Laboratory incidents, and Change controls.
● Participation in internal, external, regulatory audits and conducting self- audits.
● Maintaining a set of procedures supporting to the quality control system (GLP and GMP techniques implementation).
● Professional / regulatory training to be arranged for the team as requirement. Ensure 100% participation of desired team in training s against CAPA s.
● Maintaining a system of methods and specifications for all materials and products.
● Managing the laboratory teams and determining work priorities. Manpower planning.
● Ensuring the investigation on LIR, OOS, OOT boarder line results. Involving in the OOS and deviations from QA, Production, warehouse and other like departments. Lab investigations must be closed within time frame.
● Review/Approve Risk assessments, Prepare/Review validation documents like VP, UFRS, SDCS, TM, 21 CFR part 11 compliance assessment, IQ, OQ, PQ Test scripts, Electronic Record & Audit Trail verification test procedures and Validation summary report etc.
● Preparation and review of specification of RM/FP/STP/SOP.
● Ensure the maintain and calibration of all QC instruments
● Implementation of effective CAPA and monitoring of it timely.
● Review of batch records, analytical documents, audit trail and disposition of batch(s).
● Supervising and directing the lab work for lower-level associates.