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Ramesh Javali.cv

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Ramesh Javali.cv

  1. 1. CIRCULAM VITAE Ramesh A. Javali Email id: ramesh.javali20@gmail.com rjavali@rocketmail.com Contact no: 9972643190 Seeking a leadership assignment in Quality Assurance/Quality Control in the Pharmaceutical sector to utilize extensive experience and deliver best-in-class results. • Versatile Analytical Chemist with 25 years of rich leadership experience in QA/QC with reputed pharmaceutical companies. • Well versed in managing quality control of raw materials, packing materials, in process and finished products maintaining targeted quality levels. • Expertise in managing modern analytical labs equipped with HPLC, GC, FT-IR, auto-titrator, dissolution apparatus, LBPC and viscometer. • Sound experience in developing and validating analytical methods, process validation, forced degradation, validity of stability indicating methods, qualification of areas, analytical instruments and preservative validation. • Hands on experience in trending chemical and microbial quality of air, water, equipment, material and products. • Extensive experience in preparation and review of analytical methods, specifications, standard operating practices, standard testing practices and maintenance and calibration of instruments. • Well versed in investigating OOS and OOC and customer complaints and implementing effective corrective and preventive measures (CAPA). • Experienced in method transfer for new products and new customers. • Comprehensive understanding of GMP, GLP, SUPAC, CDER and ICH guidelines and ensure compliance with requirement of various regulatory regimes. • Capable of preparing for and successfully facing audits by MHRA UK, HSA Canada, TGA and major customers like Pfizer, GSK and Wyeth. • Skilled in building competent QA/QC teams through continuous coaching, mentoring training and development. • Proactive result oriented professional delivering consistent excellence through effective communication, coordination, planning and execution. • Developed and implemented the process of Manufacture of Chondroitin Sulphate (Bulk Drug) right from Literature survey to commercial manufacturing scale first time in INDIA through the modern extraction methods. • Conducted the comparative dissolution and fit factor (F1, F2) for Solid oral doses (Tablets and capsules) as per SUPAC guidelines. PROFESSIONAL EXPERIENCE Present work: SARVOTHAM CARE PVT LTD, Baddi PRESENT DESIGNATION: DGM QA / QC • Report to the Vice president QA and lead a team of 60 in managing all QA/QC activities of the company covering more than 200 formulations in the form of tablets, capsules, oral liquids dry syrups and health care products. • Review and approve of batch records and analytical records prior to submission to regulatory bodies. Ramesh A. Javali: Page 1 of 4
  2. 2. • Review and validate all SOPs and specifications for the plant to comply with GMP and requirements of various regulatory bodies. • Review stability data of all ongoing and developmental batches to ensure maintenance of prescribed shelf life. • Vet and approve of all product dossiers to be submitted to regulatory agencies. • Develop annual budgets for the QA/QC department and ensure adherence to budgetary norms. • Responsible for review of all quality documents, change control and out-of-specification (OOS) investigations. • Train all personnel including QA/QC and production on GMP requirements. ANGLO-FRENCH DRUGS AND INDUSTRIES LTD, BANGALORE, DESIGNATION: DGM QA / QC, Reporting to: Chairman & MD (AFDIL) Aug2013 to Feb.2015 Responsibilities: Responsible for ensuring the consistent quality of all products produced and/or sold by the company through development and management of appropriate quality systems as per the GMP requirement. Provides assistance to the Managing Director in developing overall company strategy towards continuous improvements on Quality. CENTRAL • Initiate & implement strategic moves towards continual improvement, quality systems for company’s future growth and sustenance. Benchmark world class quality systems and upgrade our systems, • Set benchmark to meet customer expectations in order to assure product quality and customer loyalty. Conduct periodic customer visits, assessment and corrective action/improvements. Initiate improvement plans from findings of customer surveys. • To prepare and control department budget. Rationalize the departmental activities in order to reduce the analytical cost. • To plan and co-ordinate for the preparation of any external clients domestic, FDA, international clients in order to ensure compliance. Analyse gaps and take initiatives to reduce the gaps. • To plan and execute training modules on GMP, SOP’s GLP and other quality areas’ • Identification and finalization of New Location (Including Audits) with coordination with GM- Operations. • Finalization of Specification, Coordination to get product right at first time. (Supporting to GM- Operations) PERIPHERAL • Periodic review of the Quality Plan. Periodic review of raw material and packaging material specifications, Review of APQR and approve the QMS documents like validation, Qualification , change control , deviation and strategic quality decisions etc • Ensures timely goal setting, performance feedback and rewards and Recognition to improve the performance further. Plan the manpower by nos. and skills. Initiate actions to develop multi- skill. • Ensure compliance to centralized QA activities viz. customers/GMP audits, To ensure Sample analysis of trial and stability samples • To guide for preparation of product dossiers from Quality modules SARVOTHAM CARE PVT LTD, Baddi, http://www.sarvothamcare.net, Deputy General Manager QA/QC, Aug2011 to July.2013 • Report to the Vice president QA and lead a team of 45 in managing all QA/QC activities of the company covering more than 200 formulations in the form of tablets, capsules, oral liquids dry syrups and health care products. • Review and approve of batch records and analytical records prior to submission to regulatory bodies. Ramesh A. Javali: Page 2 of 4
  3. 3. • Review and validate all SOPs and specifications for the plant to comply with GMP and requirements of various regulatory bodies. • Review stability data of all ongoing and developmental batches to ensure maintenance of prescribed shelf life. • Vet and approve of all product dossiers to be submitted to regulatory agencies. • Develop annual budgets for the QA/QC department and ensure adherence to budgetary norms. • Responsible for review of all quality documents, change control and out-of-specification (OOS) investigations. • Train all personnel including QA/QC and production on GMP requirements. ELEGANT DRUGS PVT LTD, Hubli, http://www.elegantdrugs.com, Deputy General Manager QA/QC, Feb 2011 to July 2011 • Report to the Managing Director and lead a team of 23 in managing all QA/QC activities of the company covering more than 200 formulations in the form of tablets, capsules, oral liquids and dry syrups. • Review and approve of batch records and analytical records prior to submission to regulatory bodies. • Review and validate all SOPs and specifications for the plant to comply with GMP and requirements of various regulatory bodies. • Review stability data of all ongoing and developmental batches to ensure maintenance of prescribed shelf life. • Vet and approve of all product dossiers to be submitted to regulatory agencies. • Develop annual budgets for the QA/QC department and ensure adherence to budgetary norms. • Responsible for review of all quality documents, change control and out-of-specification (OOS) investigations. • Train all personnel including QA/QC and production on GMP requirements. • Update specifications of various formulations to meet changes and updates of pharmacopoeias. • Successfully obtained various licenses under drug regulatory and factory rules requirements. MICROLABS LTD, Bangalore, http://www.microlabsltd.com, Manager QC ML-14, Nov 2009 to Dec 2010 • Reported to the VP Quality Control and led a team of 44 in managing the QC function of the unit. • Managed the successful method transfer from the R&D Centre to the manufacturing plant. • Reviewed and approved the microbial trends in the plant. • Implemented all requirements for operating sterile facilities. • Conducted stability studies and assisted top management in updating stability indicators. • Successfully cleared audits of UK MHRA and various customers. MEDREICH LTD, Bangalore, http://www.medreich.com, Manager QC, Sep 2004 to Oct 2009 • Reported to GM Quality and EVP Quality and managed all Quality Control activities of the plant. • Validated analytical methods, stress study and stability indicating methods and developed new methods. • Ensured quality control of raw materials, packing materials, in-process and finished products and updated reports in SAP. • Identified training needs of QC personnel and organized necessary training in various analytical methods. • Conducted sensitive analysis of highly unstable solutions like Betalactums. • Successfully faced audits by MHRA and customers and won appreciation for maintenance of quality documents and good laboratory practices. • Consistently exceeded targets and ranked first in quality delivery among all units of the company. Ramesh A. Javali: Page 3 of 4
  4. 4. PREVIOUS WORK EXPERIENCE • KEMWELL PVT LTD, Bangalore, Manager QC, Apr 2000 to Sep 2004 • TILRODE CHEMICALS, Bangalore, Manager QC, Oct 1998 to Mar 2000 • GLAND CHEMICALS PVT LTD, Bangalore/Hyderabad, Manager QC and Development, Feb 1992 to Sep 1998. • KEMWELL PVT LTD, Bangalore, Analytical Chemist, Oct 1989 to Jan 1992 • GLAND CHEMICALS PVT LTD, Bangalore, Analytical Chemist, Jun 1987 to Sep 1989 EDUCATION • M.Sc. Analytical Chemistry, Gulbarga University, First Class, University Gold Medallist, 1983. TRAINING • GLP, GMP and Validation – ISPE • HPLC Column safety, care and selection – Waters, Schimadzu PERSONAL PROFILE • Date of Birth: 20 March 1960 • Languages: English, Hindi, Kannada, Telugu • Nationality: Indian • Address: D.No:57/4, Ist D Cross, Venkadri Nilaya, Beside Indian High School, Basaveshwar Nagar, Bangalore, 560079 , Karnataka State • Preferred Job Locations: Bangalore, Hyderabad, Pune, and Ahmedabad. • Permanent Address: Ramesh.Javali, Near SJJM high school , BYADGI -581106, Dist Haveri, Karnataka Ramesh A. Javali: Page 4 of 4

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