TUSHAR M. PANDHARKAR

 To Prepare and Review Standard Operating Procedure (SOP).  To provide Training on SOPs.  Performance of In Process Quality Assurance (IPQA) activities in various departments, in order to ensure cGMP compliance. Sampling of In-process, Finished bulk, Hold time and Finished product, as per the product BMR/BPR or approved protocol.  Verification of the timely completion of Batch Manufacturing and Control Records.  Withdrawal of Control, Stability, Micro sample of the Finished Products.  Calibration of different IPQA Instrument.  Investigation and reporting Deviations, Changes, and Incidence observed in various departments.  Monitoring of dispensing activities in Ware House department.  Ensure Execution of Calibration schedule.

 Sampling of Packing material, Intermediates and Finished products.  To ensure proper document control on Issued document and Master documents.  Control sample and Stability sample management.  Issuance and retrieval of Log books, specifications, BMR, BPR, SOP’s, Protocols etc.  Preparation and Review of Departmental SOP’s for GMP compliance.  To execute and support validation activities such as- • To review protocols and support execution of process validation. • To review the validation reports.