9,Kshitij Kudale-PatilS.V No-53/2/1,Vadgaon B.K PUNE- -411041
Phone: (020)24352883, Mobile: (+91) 98 60 36 36 66 Email: email@example.com
Skilled Quality management system Head of Dept with extensive experience in the Pharmaceutical formulations/ Vaccine Biotech Industries. Experienced in QA 25 years in Quality management.
• An excellent planner and organizer with the ability to manage a staff of Quality QA/QC/RA Staff to reach goals while strictly adhering to budgets and, cGMP, GLP, GCP and ICH / Post Approval Inspections, FDA, USP, EP,JP requirements.
• Perform GAP analysis and site audit report and compliance with CAPA.Pharmaceutical firms.
• Responsibilities- Vendor Qualification, Global Trainer – Training planning, Review of APQR, Equipments-Qualification, Analytical Validation, Process Validation ,Photostability, Stability Stability study. Approval Quality policy /Manual ,preparation of MVP, BMR MFR, SOP approval authorization /Change Control, OOS /deviation ,Rejection ,Disposals , Preparation of DMF/ SMF COS/CTD, Registration Product to FDA .Regulatory authorization ,.
• Review planning Monitoring, tracking, Quality operation with respective production in timelines, budgets, etc
• More than 24 years in management positions for Quality Control / Quality Assurance / R&D / Regulatory Affairs with multi-national bio pharma/ pharmaceutical companies.
• Contract manufacturing, Technical Services & Business development and support to export and technical support to Customer.
• During the past 20 years, provided laboratory management through all governmental inspections e.g. FDA, CDSCO and international auditor from Germany, French, Hungary, Brazil canda/USA.
• Self-starting, team player with strong training ability .Extensive Staff training experience