Vijay Bidawe
Chief Manager @RPG Life Sciences Ltd.
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WORK HISTORY
Chief Manager @RPG Life Sciences Ltd.
Responsible for site Quality Control Department functions independently, Planning & execution of work from sampling to release of materials and stability studies adhering to GLP and cGMP requirements. Responsible for handling Analytical Method Verification and Transfers, Validations3. Responsible for the Qualification, Calibration and maintenance of Analytical equipments, qualification of working standards, Investigation OOS, OOT, Laboratory incidents and CAPA implementation, Audit observation and its compliance4. Recruitment, Training and qualification of laboratory staff5. Coordination with inter departments and global cross-functional teams like Production, CQA, RA, ADL, F&D, as required
EDUCATION
K.K.W. Pimaplgaon (B) Nasik
B.Sc.
Poona College of Pharmcy, Pune
PG Diploma
Marathwada University
M.Sc.
ABOUT VIJAY BIDAWE
With over 24 years of experience in pharmaceutical Quality Control and Assurance, I am currently the Chief Manager at RPG Life Sciences Ltd, leading a team of 60 professionals. I specialize in formulations and APIs, holding FDA-approved certifications in \'Instrumental and Chemical Analysis\' from the Maharashtra and Gujarat State FDAs. My expertise includes instrumental analysis, troubleshooting, management, regulatory requirements and compliance. SAP system, LIMS, LMS, DMS, EQMS and instrument related software Identification, planning and management of capital and operation expenditure as per the requirement and its control. Review and approval of Specification, STP’s and SOP’s, Stability study, Method verification and transfer protocols and reports Good Communication skill and dealing with cross functional teams like Production, PPIC, CQA, RA, ADL, F&D Accomplishments 1. Key player for USFDA Audit at Lupin Ltd, Mandideep in 2005, Aurobindo Pharma Ltd, Bachupally in 2007, Wockhardt Ltd in 2010, Hospira Ltd in 2015 with no critical observation in Quality control department. Key role for MHRA audit at Lupin Ltd, Mandideep in 2004, Aurobindo Pharma Ltd, Bachupally in 2008, Wockhardt Ltd in 2009, Hospira Ltd in 2014 3. Presentation of quality control activities for WHO, CDSCO FDA inspections and other regulatory bodies such as Ukraine Medicine and drug Control Authorities, Colombia National Food and Drug Surveillance Institute and customer audits of reputed clients 4. Designed & modernized the QC Laboratory facilities as per the recent GLP norms in current as well as previous organization in coordination with project team. Identification, evaluation, Procurement and qualification of various analytical instruments. Demonstrated the technical and analytical skills at various investigation of batch failures and root cause identification 6. Actively involved in various cost optimization project with respect product, processes, and analytical activities and reduction of testing at contract testing laboratory by developing the capabilities at site 7. Upgrading the standards of the documentation, SOPs and QMS related to quality Control department
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