Pharmaceutical Quality Control and Quality Assurance Consultant

Technical Consultant #2395

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.

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.

Credentials

License

Languages

M.Sc. Biochemistry, Bangalore University, Bangalore, Karnataka, India
B.Sc. Chemistry, Botany and Zoology, Bangalore University, Bangalore, Karnataka, India