mortu lotlikar

Assistant department head, responsible for entire Quality Assurance and Control activities of Pharma APIs, Agrochemicals, Dyes and Pesticides and Plastics and Adhesives division

* Responsible for entire Quality functions and Regulatory Affairs of MJ Biopharm. * The company is pioneer in biotechnology products such as Insulin from last 40 years. Dry powder Injections of Cephalosporins and Tablets. * The plant is approved by almost more than 10 authorities including MHRA, MCC, Various Asian and African countries etc. * State of Art Plant with Foreign alliances and colaborations * Strong exposure to Quality Assurance of Sterile Products such as Small Volume parenterals, Insulin productions and Dry powder Injections. * Well versed withto Validation of Aseptic processes, * Keep the plant updated with all latest guidelines. * New products launching for Regulated Markets

* Corporate QA, QC and Regualtory Affairs function of RPGLS. * Corporate portfolio strong exposure to both APIs and Formulations. * Responsible as primary regulatory representative of the company. * Plan, prepare, review FDA and International submissions (DMF, COSs, ANDA and Formulation dossiers in Europe, US and Semi-regulated countries. * Submission in CTD formats * Annual reports, updates, supplement to DMF * Achieved two MHRA approvals for Ankleshwar Formulation Plant * Achieved Two TGA approvals for Navi Mumbai API Plant * Achieved WHO for RPG plants first time.

* Corporate QA / QC and Regulatory Affairs function. * Implementation of QMS in all Medley Plants. * Preparation of Formulation Dossiers and submissions * Answering the queries on deficiencies * Launching of new products * Quality planning of third party products. * Liason with FDA and other regulatory bodies * Technical support to the plants

* Responsible for QA/QC and Technical Services Functions. * FDA Liasons * Projects handling. * Implementation of Quality Management System * Support to Regulatory Affairs

* Responsible for entire Quality Assurance and control Function of Wockhardt Limited, Chikhalthana, Aurangabad Plant. * Support to Regulatory Affairs, * Handled more than 20 class I authority audits which includes, USFDA, MHRA, TGA, Hungary, MCC, and more than 10 non regulatory countries that includes African, Latin American countries, * WHO and Local FDA, * Began the exposures to US DMFs, EDQM COSs, US ANDA etc.

* Analysis of Pharma APIs, Pharma Formulations, Agro Chemicals, * Microbiological analysis of Antibiotics, Vitamines, Microbiological work under GMP, * Production of Agro and Pharma formulations (Last 4 years) * Major Area of competancy was QA and QC

S. Zhaveri Pharmakem Pvt Limited Pharmaceutical firm established in year 1951 as trading company and sole importers and distributors for many highly purified key excipients required for regulatory formulations to be filed in US and EU. In about 1990 the company started its CRO activities mainly for overseas clients which included development of formulations and analytical support to overseas clients. In 2012 a full fledge manufacturing plant was constructed with the aim to export the products to US and UK. The plant is still under commissioning and under Qualification and likely to start commercial production in June 2015.

AIC by examination is equivalent to MSc (Analytical) wide G.O. No. F.18-36/57-T.5 and recognized by Drugs and Cosmetics Act Activities and Societies: Associateship Diploma from Institution of Chemists, Kolkata (by Examination) with subjects Analysis of Pharmaceuticals and Foods.

Activities and Societies: Managerial Skills Planning of resources Shop floor Planning Activities

Activities and Societies: Pharma Technology