Log in

Login to your account

Username *
Password *
Remember Me
Loading...
Show More
Add this resume to contact form Yes No
Back to Search Result GO

Pharmaceutical Quality Control and Quality Assurance Consultant

Technical Consultant #2395


Expertise

  • Pharmaceutical Quality Assurance and Regulatory Affairs.
  • Compliance audit, Quality Operations and Regulatory Submissions.
  • Design and implementation of Quality Systems and regulatory compliance programs.
  • Domestic and international quality and regulatory compliance.
  • Managing contract / vendor supply chain quality programs.
  • Developing and delivering GMP, GDP, DI procedure training programs.
  • Leading the Quality efforts to successfully remediate recurring failures.
  • Generation, maintenance and revision of SOP's, specifications, procedures, batch records, training, OOS investigations, and other documentation systems.
  • Supporting firms in remediation for regulatory actions such as Warning Letters.

Experience

Undisclosed Company, Head Quality, 2017 - Present

  • Direct the manufacturing of: API (Active Pharmaceutical Ingredients and intermediates, formulations, nutraceuticals and drug discovery
  • Coordinate at Corporate level for 2 API sites, one nutraceutical site and one drug discovery site, improving overall quality culture.
  • Remediate recurring failures.
  • Set up and monitor quality metrics for sites,
  • Manage Quality Council meetings for improvements.
  • Update sites on current GMP and DI expectations through regular awareness sessions.

Dr. Reddy's Laboratories Ltd., Hyderabad, India, Director, Quality, 2015 - 2017

  • Coordinate at Central level for eight API and formulations sites, improved investigation skills through overview, training and direct involvement, flow charts, and templates.
  • Primary contact for customers for faster resolution of queries, overview of audits.
  • Coordinate at Central level for Quality Technical Agreements of all API sites.
  • Training on Technical writing skills through regular scheduled programs.
  • Impact assessment for regulatory actions.
  • Review and remediation's of gaps in investigations with respect to complaints, OOS and deviations.

Neuland Laboratories Ltd., Hyderabad, India, Head, Quality Compliance, 2014 - 2015

  • Assuring compliance at two sites and research and development with applicable federal, local and international regulations.
  • Primary contact for FDA and other regulatory agencies and Customers for audits and queries.
  • Analysis of potential risks and gaps that need corrective and preventive action.
  • Direct and manage internal audits, mock audits.
  • CAPA management.
  • Auditing vendors and suppliers for their quality systems, cGMP and cGLP compliance.
  • Approval of Product development reports and Validation reviews.
  • Training for improvement in QMS and Regulatory updating.

Fermenta Biotech Ltd., Mumbai, India, General Manager, Corporate Quality, 2010 - 2014

  • Managing the manufacturing of: API, Pharmaceutical, Nutraceuticals, Fermentation based, animal premixes and environmental based products.
  • Primary contact for FDA and other regulatory agencies and Customers.
  • Qualification and maintenance of QMS of contract manufacturing organizations like Sterile, oral dosage forms, API, intermediates and external test labs.
  • Technology transfer.
  • Auditing for ensuring compliance of company and contract sites, ensuring consistency in quality operations across plants.
  • Leading teams for QRM, Validations, Qualifications, Training and Vendor Management.
  • Responsible for all activities of Quality Department to ensure compliance with company, compendium and regulatory requirements.
  • Support and lead regulatory submissions: Regulatory dossier filing in US FDA, Canada and EDQM.
  • Dossiers submission for food and feed products to EFSA, MOH Iran, CFIA Canada, MOH Russian Federation.

R.L. Fine Chem,, Bangalore, India, Senior Manager, Quality Assurance, 2003 - 2010

  • Quality Risk Management - FMEA, Fish bone, HACCP, HAZOP, Fault tree.
  • Internal audit - Quality systems.
  • Document Control and Management.
  • Training modules - GMP and job specific through presentations, practical, tests.
  • Handling of Change Controls - impact assessment, risk analysis, approval.
  • Handling of Incidents and Deviations - remediation.
  • Investigation of OOS (Out of specification) and OOT (Out of trend).
  • Qualifications (including HVAC, Water system) - URS, FAT, SAT, DQ, IQ, OQ, PQ.
  • Vendor qualification and Management - Raw materials and packaging materials.
  • Validation - Process, Analytical, Cleaning and Equipment.
  • Product Release - review of batch records, analytical records, etc.

Manager; Quality Control-Active Pharmaceutical Ingredients, 1994 - 1998

  • Total responsibility of analytical testing of all raw materials, packaging materials, in process, finished products and stability testing.
  • Responsible for generation and update of specifications, procedures and SOP's.
  • Method development and Validation.
  • Product release.

Agro Biochem India Pvt Ltd., Bangalore, India, Manager, Quality A&C, 2000 - 2003

  • Supervise and oversee quality assurance and quality controls for the manufacturing of food based colors, carotenoids.
  • Directed all activities of the quality department, including raw materials, packaging materials, intermediate, finished product testing, validation, as well as stability testing to ensure compendium, company, corporate, and regulatory compliance.
  • Internal audit - Quality systems.
  • Documentation responsibilities included SOP's, specifications, and procedures and stability data review of new and existing products.
  • Analytical method development, validation.
  • Audit compliance for Customer and Regulatory inspections.
  • Product Release - review of batch records, and analytical records.
  • Instrumental analysis.

Provimi Ltd., Bangalore, India, Deputy Manager, 1988 - 1993

  • Document Control and Management for this manufacture of Manufactures: Veterinary pharmaceuticals and Animal feed premixes.
  • Product Release - review of batch records, and analytical records.
  • Instrumental analysis - HPLC, GC, FTIR, and UV spectrophotometry.

Honors & Publications


Credentials

  • Black Belt, Six Sigma
  • Post Graduate Diploma in Business and Industrial Management
  • Qualified GMP auditor
  • Qualified Internal auditor for ISO 9000:2008

License

  • Approved QC Chemist, Drugs Control, India

Languages

  • English
  • Hindi
  • Kannada

Education

  • M.Sc. Biochemistry, Bangalore University, Bangalore, Karnataka, India
  • B.Sc. Chemistry, Botany and Zoology, Bangalore University, Bangalore, Karnataka, India
Back to Search Result GO