Pharm Nutrec

Pharm Nutrac Consultants

Girish Valiyare

Dr. GIRISH R VALIYARE

Mobile No: 9321608282, 9820703077

Website: https://pharmnutrac.in

MSc PhD (Chemistry-Mumbai University)

Ex- Director Technical Services & Business Development.

RAPTAKOS, BRETT & CO LTD THANE, MAHARASHTRA

After completing a successful and satisfying career in the industry for 27 years and being awarded the IDMA, Outstanding Analyst Award for the year 2019, I took a conscious call to take up consultancy services.

The main objective of this step is to explore more areas and get in touch with various spheres of activities alongwith experts in their respective fields.

Apart from my work portfolio at Raptakos Brett & Co Ltd I have been involved in the selection panel of Full time Management courses conducted by reputed Wellingkar Management institute, at Matunga.

Past few years, I have gained experience of liasoning with Joint FDA Commisioner's FDA for Thane, Raigad and Pune regions, as well as with Asst.Commisioner's of Pen, Satara and Thane FDA offices.

I have got associated with Pune based Futurol enterprises as Senior Associate consultant . The association will be project specific ventures. I am also in collaboration with LabPulse Analyticals, Ambernath for instruments and laboratory set up related requirements.

Services Offered

  • Product development, specific to nutritional products, API’s and Pharma formulations from R & D to stability to scale up to product launching..
  • Analytical method development, method validation for Pharma and Food products.
  • Trouble shooting, investigation into product related problems.
  • Audit of manufacturing facility to do GAP analysis to meet GMP norms. We can do audit for API/Formulation units. I have personally carried out GMP audits of 12 major manufacturing units .
  • Laboratory set up- including designing, providing lab furniture and instruments.
  • Providing gas piping lines/ fume cupboards for instruments like GC, AAS etc.
  • Supply of sophisticated instruments including GC, HPLC, FTIR, HPTLC, Spectrophotometers etc from National and International manufacturers, with whom we will be having Channel partnerships. The added advantage will be with respect to our knowledge and experience for problem solving, in case the customer needs inputs.
  • Dairy products- from milk processing to different milk products, from R&D stages to technology transfer.
  • Also considering Green field chemistry, involving Continuous Process Reactors for mfg of APIs.

Credentials

academic

  • Certificate of Merit from University of Bombay for standing First in M.Sc., Analytical chemistry, (Part I).
  • Certificate of Merit from University of Bombay for standing Second in M.Sc., Analytical chemistry, (Part II).
  • Certificate of Merit from K..V. Pendharkar college for standing Second in B.Sc., Chemistry.
  • Certificate from Indian Pharmaceutical Congress for presenting a research paper at 43rd IPC, Goa.
  • Certificate from Indian Chemical Society for presenting a research paper at the Research Scholars Meet, 29th feb, 1992, Vidyanagari, Bombay.
  • Academic related experience: During Ph.D.
  • Instructor for M.Sc. practicals in Ruia college and as an Expert for M.Sc. practical exams, Bombay University.
  • Instructor for Post Graduate Diploma course in Analytical Chemistry, Ruia college.

industrial

  • IDMA, Outstanding Analyst Award for the year 2019.
  • Selection panel member for two year full time PGDBA program, Welingkar Institute of Management, year 2020.
  • Invited for lecture at NIPER, Chandigarh, for the Staff from Government Testing Laboratories under Capacity building project held in September 2005.
  • Invitation from USP’s India, for inaugural meet in presence of CEO Roger Williams, for Stakeholder Forum group as Founder member, in 19th January 2011.
  • Letter of appreciation from Henz Lehmann, Plant Manager, Ciba Santa Monica plant, Goa; for personal contributions made for production activities at Goa.
  • Outstanding performance award and certificate Letter from Raptakos, Brett & Co. Management in 2003.
  • Presentations on varied topics including Biotechnology, Management concepts to Core group team.
  • Management Representative for implementation of ISO 9001: 2008/ 2015 for Thane factory and Head Office.
  • Facilitated the implementation of NABL certification for Raptakos, Brett Test lab from 2015.
  • CRO activity specific to Analytical and stability studies with MNC for Nutrition products for past 8 years, where the business grew very significantly to about Rs15 million p.a.
  • Involved in CRO project for South East Asian market for AMD, AMV, stability studies till successful transfer of Methods.
  • Method Development and AMV for numerous product range including Pharma, Foods, Herbals.
  • Involved and responsible for many other Key company related activities including investigations into problems related to products, processes, materials etc.
  • Involved in activities of company Good Manufacturing Practices [GMP], Plant Management Group, and Core Group meetings.
  • Vendor audits and approvals for Pharma and Food actives as well as Packing materials. Third party analytical activities for reaction monitoring and process control for critical high valued product.
  • Experience in analytical related activities of Pharmaceuticals, Nutritional products, Pigments, Agrochemicals, Bioequivalence studies, Speciality/ fine chemicals.
  • Involved in liasoning activities related to FDA- Thane, Pen, Satara, Pune, Chennai, Bandra FSSAI, DCGI- New Delhi.. Involved in co-ordination and suggestions for New Product Development concepts.

ADDITIONAL INFORMATION SPECIFIC TO ANALYTICAL WORK IN INDUSTRY

  • RAPTAKOS, BRETT & CO. LTD
  • Development and validation of analytical methods including HPLC, GC, UV, fluorimetry, titrimetry methods for more than 90 formulations which include formulations containing: vitamins & minerals- capsules and liquid preparations, controlled release pellet formulations, conventional capsule/ tablet formulations, liquid preparations, enzyme formulations etc.
  • Development and validation of analytical methods for twelve Ayurvedic formulations. Methods include development of fingerprint/ identification of marker compounds by HPLC/ spectroscopy.
  • Development and validation of analytical methods for dermatological product, Sunscreen cream and lotion.
  • Development and validation of methods for analysis of more than 15 ingredients in the form of mainly vitamins and minerals in each formulation for eighteen nutraceutical products.
  • Validation of analytical methods for export worthy products as per International Conference on Harmonization [ICH] guidelines.
  • Analytical support for Exports dept. for registration of products in countries like Vietnam, Brazil, Thailand, Sri Lanka, Myanmar, Tanzania, Uganda, Ivory Coast etc..
  • CIBA – GEIGY RESEARCH CENTER, WORKED AS ANALYTICAL DEVELOPMENT EXECUTIVE IN CHEMICAL DEVELOPMENT DEPT.
  • Extensively involved in the development of analytical methods using HPLC, GC, FTIR, UV, and autotitrators for the reaction monitoring and final product analysis of- Pharma products, Agrochemicals, Pigments, Polymers etc.
  • Carried out HPLC method development/ standardisation and analysed plasma samples of Bioequivalence projects for- Rifampicin, Carbamazepine, Diclofenac sodium CR formulation. Studies were conducted at K.E.M. and samples analysed at Research center.
  • Successful implementation of carrying out lab scale to kilo scale to production of palladium phthalocyanin project at Herbert Brown lab, and Modepro, third parties. Involved for providing total analytical support and training of technical skilled personnel to handle and analyse on UV and HPLC.
  • Worked in pharma production for one month at CIBA plant, Goa.
  • APTE AMALGAMATIONS, WORKED AS QC CHEMIST.
  • Worked as Quality Control chemist for seven months in the bulk drug division. From sampling to in-process testings to API analysis.