Expert in Regulatory Affairs, Technology Management, Pharmaceutical Industry, Turnaround Management
Expert ID: 725858 India
He has successfully applied cGMP during his tenure at Ipca, Ranbaxy, Kopran, Actavis / Alpharma, and plant got approved by various regulatory agencies. He has got experience in the development of various APIs and Dosage forms. He worked with world's top ten generic company and worked on the end to end development of generic drugs ranging from API development, API manufacturing, DMF filing, Dosage form Development, bio batches, ANDA filing, commercial production and product launch. He has worked on the synthesis of heterocyclic compounds during Ph.D. He has hands on experience in nonaseptic process validation during his employment and association with various companies. Organic chemistry was his specialization during M.Sc. and Ph.D. and worked in industries who are involved in manufacturing or organic compounds. He helped the alliance partner in preparing for PAI and company got approved without any 483. Presently assisting the client for PAI.
He provided regulatory consultancy to one of the client for the preparation of US FDA Pre Approval Inspection. This is an extensive green field project which includes creation of Quality Management System, helping the client in compilation of Dossier, Process Validation, and Cleaning Validation and conducting mock PAI.He audited API manufacturing facility to ascertain client's preparation for inspection and suggested the ways to correct the gaps.
|Year: 1982||Degree: Ph.D||Subject: Synthetic Organic Chemistry||Institution: National Chemical Laboratory, Pune, India|
|Year: 1978||Degree: M.Sc.||Subject: Organic Chemistry (Drugs)||Institution: Vikram University, Ujjain, India|
|Year: 1976||Degree: B.Sc.||Subject: Chemistry, Botany, Zoology||Institution: Vikram University, Ujjain, India|
|Year: 1987||Degree: P.G.Diploma in Production Management||Subject: Production management, marketing, finance mgt.||Institution: Marathwada Univerity, Aurangabad, India|
|Years: 2008 to Present||Employer: Undisclosed||Title: Associate||Department: Regulatory Affairs||Responsibilities: He works with clients in the pharmaceutical industries to develop quality assurance and regulatory strategies for compliance with US FDA and European regulations by:
• Conducting assessments of client studies, procedures, and programs to determine compliance.
• Development and adherence to Quality Systems;
• Development and control of various documents.
• GMP for process and facility;
• Validation with respect to,
-Validation Master Plan (VMP) drafting, incl.facilities, utilities, equipments, process &
-Generating of validation protocols and reports;
- Validation training;
- Execution of DQ, IQ, OQ & PQs ;
• cGMP and GLP compliance with .respect to,
- Auditing (self-inspections and suppliers);
- Preparing for inspections and pre-approval inspections;
- Sterile and aseptic production techniques;
- Documentation control and support and Standard Operating Procedures (SOPs).
|Years: 2005 to 2007||Employer: Actavis Group / Alpharma Inc.||Title: Technical Director (Asia)||Department: Alliance Management||Responsibilities: He managed Human Pharmaceuticals Div. development programs and initiatives including product Research & Development, Technical Services organization projects, Business Development due diligence support and Scientific Affairs Regulatory Compliance activities performed through one or more partner companies in the Asian Sector.
• He proactively managed cross-functional teams between parent and partner organizations to include the areas of Research & Development, Technical Services, Manufacturing, Operations, Quality, Regulatory, Marketing, Intellectual Property and Legal to ensure that Scientific Affairs objectives including completing ANDA and MA filings and launching new products are achieved in a timely and GMP compliant manner.
• He proactively managed cross-functional teams of technical and non-technical personnel to assure efficient technical transfer of new products/processes to commercial operations and to prepare the organization for FDA and European regulatory authority pre-approval inspection (PAI) audits.
|Years: 2000 to 2005||Employer: Kopran Limited, Mumbai, India||Title: Vice President - Technical||Department: Profit center -API||Responsibilities: - He functioned as a change agent in evaluating all operations, developing / implementing sound manufacturing strategies to optimize resources and equipments while ensuring product quality and timely delivery.
- He defined and recommended mfg. objectives, develop specific short-term and long-range plans and program together with supporting budget requests and financial estimates.
- He continually and aggressively reduced the business unit’s cost position. He optimized production while driving efficiency.
- He identified and prioritized opportunities to improve overall gross margins.
- He directed, reviewed and approved the development of objectives, policies and programs for operations activities involving sourcing, supply chain mgt., quality, manufacturing, mfg, engineering, projects, regulatory affairs and process development.
- He provided leadership on production-related procurement by developing strategies and objectives along with the strategic sourcing team to identify and develop high-quality, low-cost suppliers on a worldwide basis.
- He was actively involved in promoting key strategic alliance partnerships, new business development, joint ventures and technology transfers at an international level.
|Years: 1996 to 1999||Employer: Ranbaxy Laboratories Limited, Dewas, India||Title: General Manager - Manufacturing||Department: Unit Head -API||Responsibilities: His overall responsibility was for API manufacturing at site.|
|Years: 1993 to 1995||Employer: Ipca Laboratories Ltd., Indore, India||Title: General Manager||Department: Profit centre- API||Responsibilities: He had multi locational responsibility manufacturing API and APIs intermediates.|
|Years: 1990 to 1993||Employer: Stellar Chemical Laboratory, Derol, India||Title: Works Manager||Department: Profit Center - API||Responsibilities: He set up R & D Center, Pilot Plant and commercial plant and managing commercial production of APIs.|
|Years: 1989 to 1990||Employer: Jayant Vitamins Ltd., Ratlam, India||Title: Manager - Process Control||Department: Process Control / R & D||Responsibilities: He managed the Process Control and R & D departments|
|Years: 1988 to 1989||Employer: Nicholas Laboratories India Ltd., Mumbai, india||Title: Manager - Bulk Drugs||Department: API||Responsibilities: He set up API division which includes setting up of R & D Center, pilot plant and commercial plant for the manufacture of APIs.|
|Associations / Societies|
|He is a Member, Indian Institute of Management, Ahmedabad and Administrative Staff College of India Alumni Association.|
|He has been: Secretary, Chemical Association during M.Sc. and Secretary, Student Union during B.Sc.|
|Awards / Recognition|
|• Significant Performance Award by Wockhardt and helped the company in winning Award for R & D Efforts in Industry of Govt. of India.
• Merit and National Scholarships, Junior & Senior Research Fellowship of CSIR., Govt. Of India
• N.C.C. ‘B’ Certificate.
|Publications and Patents Summary|
|He published three papers in international and national journals during Ph.D and published one Us and one India patent.|
|Training / Seminars|
|He delivered various seminars and imparted training to employees at Ipca Labs, Ranbaxy Labs, Actavis partner companies and Marion Weinreb & Associates clients on the following
? GMP Basics
? Regulatory compliance
? In- house Seminars.
? Training Modules preparation
|He has hands on experieence in developing strategic alliance partnerships, auditing various facilities for future tie-ups, auditing Clinical Research Organizations and Research Centers, technical due deligence.
Developed long term contracts for supply of key raw materials
|He has expertise in various facets of Pharmaceutical industry ranging from general mgt, Operations, R & D, projects, process control, regulatory affairs, business development & partnership management.Areas of expertise include the following:
MANUFACTURING / OPERATIONS
? Cost Reduction – Quickly analyze variable and fixed operating
costs and reduce spend
? Restructuring/turnaround management – Optimize operations,
consolidate, outsource and reduce costs
? Performance Improvement – Lean efficiency transformations, best
practices, employee involvement and sustainable results
? Interim Management – Immediately step into a key
operations or manufacturing role and hit the ground running,
provide expertise, leadership, teamwork and stability
? Improving capacity & through-put
? Multi location operations.
? Team building
? Handling of cross-functional teams
? Manufacturing of Sterile API
? End-to End Development Projects
? Facility Designs
? Partnership Management
? Capacity expansion
? Quality & Research Laboratory Design
? Quality & Research Laboratory Design
? Improving capacity & through-put
? Quality System Development & Implementation
? Internal GMP Audits
? SOP Preparation
? Analytical Laboratory Audit
? Audit of CROs (Clinical).
? Audit of Vendors / Suppliers
? Audit of Research Laboratories
? Process Start-ups, Scale-Up & Commercialization
? Process Optimization
? Process Reengineering
? CMC Documentation
? Technology Transfer
? Preparation of Validation Protocols & Master Plans
? Protocol Implementation
? IQ, OQ and PQ of Systems
? Process Validation
? Cleaning Validation
? Analytical Methods Validation
? Utility Validation
|Other Relevant Experience|
|He is a turnaround expert in pharmaceutical industry specifically API industry.|
Fields of Expertise
21 CFR Part 11, Food and Drug Administration regulation, active pharmaceutical ingredient, bulk drug, bulk pharmaceutical chemical manufacturing, contract manufacturing, bulk packaging material, aseptic pharmaceutical process validation, applied organic chemistry, Current Good Manufacturing Practice, Food and Drug Administration compliance, Good Manufacturing Practice, drug development, generic drug, generic drug manufacturing, heterocyclic compound synthesis, nonaseptic pharmaceutical process validation, organic chemistry, synthetic organic chemistry, pre-approval inspection, chiral synthesis, pharmaceutical technology, antidepressant drug, calcium alginate, drug product approval, organic chemical separation, pharmaceutical manufacturer, drug formulation, pharmaceutical research and development, pharmaceutical manufacturing facility auditing, drug processing, pharmaceutical product shelf life testing, pharmaceutical capsule, organic compound process development, tablet manufacturing, pharmaceutical quality assurance, Food and Drug Administration CFR-21 part 175, organic reaction, drug stability, addition reaction, pharmaceutical industry, pharmaceutical engineering, pharmaceutical analysis, pharmaceutical quality control, antihypertensive drug, drug regulation, organic compound, pharmaceutical reactor, pharmaceutical chemistry, organic synthesis, organic chemical structure, injectable drug, Good Laboratory Practice, drug screening, dosage form, chemical analysis, anticonvulsant drug, anti-inflammatory drug