Manager, Quality Assurance at M/s. Stadmed Private Limited (2008-02 – Present)
Promoted as Manager, Quality Assurance and have been working in the same position till date.
- Controlling, maintaining, planning & implementing of all types of Q.A. Activities. At present monitoring & controlling of 130 nos. of liquid, tablet, ointment & powder products with proper procedure & documentation.
- Maintaining all types of IPQA activities, In-process Manufacturing, Filling & Packaging Records in Oral liquid, Tablets, Ointments, Injectibles, Parental & ORS powders.
- Controlling the total inflow of the product along with the Batch History, Manufacturing Instructions (MI), Formulation- Batch Manufacturing Record (BMR) & Filling & Packaging- Batch Packing Record (BPR).
- Handling & keeping the entire documentation of Products (BMR's & BPR's), Maintaining the Calibration records of Instruments, Vessels & Machinery (both in-house & outside)
- Implementing, Maintaining & Updating of Master Formula Record (MFR), Product Compliance Files (PCF), Standard Testing Procedures (STP), Standard Operating Procedures (SOP), Quality Manual (QM), Production Procedure Manual (PPM), Quality Control Manual (QCM), Quality Assurance Manual (QAM), Air Quality Manual (AQM), Water Quality Manual (WQM), Total Quality Management (TQM) & Site Master File (SMF) etc.
- Doing all types of Product Validations, Progressive & Retrospective Process validation, Manufacturing method Validation, Analytical method validation along with the required procedure, data & documentation.
- Doing all types of Instrument & Equipment Validations, Water system Validations (PW, WFI & DW), Air system Validations (HVAC & AHU) i.e. DQ, IQ, OQ & PQ.
- Managing all the 3rd party manufacturing (P2P basis) facilities out side kolkata, looking after all the technical matters by visiting the sites or by mail & phone communication.
- Doing all type of regulatory & constitutional jobs related with pharmaceuticals, endorsement, product approval, product license, renewal, certification etc.
- Doing all type of tender, manufacturing & market standing certificates, no conviction certificates, test licenses, all kind of lay out & it's approval from State & Central Drugs.
- Doing all type of art work, text matter & designs for new product approval, changes as per the pharmaceutical guidelines as per DCG (I), CDSCO guideline etc.
Deputy / Assistant Manager, Quality Assurance at M/s. Stadmed Private Limited (2006-12 – 2008-01)
Appointed as a Deputy / Assistant Manager, Quality Assurance.
Senior Executive Chemist, Quality Assurance at M/s Cradel Pharmaceuticals Private Limited (2001-12 – 2006-11)
Worked as a Senior Executive Chemist, Quality Assurance in M/s Cradel Pharmaceuticals Private Limited, kolkata having Technical Collaboration with M/s. Merck Limited, controlling all the QA activities.
QC & QA Chemist at M/s E. Merck (India) Limited (1996-08 – 2001-10)
As a QC & QA Chemist in both Chemical and Pharmaceuticals Section, both raw materials & finished goods.
Production Assistant & Production Supervisor at M/s E. Merck (India) Limited (1987-07 – 1996-07)
Started job in M/s E. Merck (India) Limited (German Multi National Company) in Chemical Division.
