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Click here or scroll down to respond to this candidateCandidate's Name , RAC, M.BIRA.Street Address HECKSCHER AVENUEBAY SHORE, NEW YORK Street Address -2410TELEPHONE NUMBER: PHONE NUMBER AVAILABLE - HOMEE-MAIL: EMAIL AVAILABLE - HOMER E S U M EBACKGROUND SUMMARY:Thirty-six (36) years of progressive experience working in increasingly responsible positions with major international drug (OTC/Rx) and biologic (Pharmaceutical / Biopharmaceutical Brand Name and GENERIC)) products and Contract Development and Manufacturing Organizations CDMO) / contract research organizations in the United States, United Kingdom, and India. Project and personnel management experience in the Global QC/QA/Audit/Compliance operations [including Vendors Facility Qualification (DQ/IQ/OQ/PQ) and Validation, Qualification Program, Hosting FDA Inspection / FDA Remedial Programs, Employee (cGMP/ GCP/GLP FDA 21 CFR Parts 50, 54, 56, 58, 210 / 211/ 503B / 600-680, 820) Training, Documentation Control, Regulatory Compliance (cGMP, GLP and GCP/ICH), QC laboratory (chemistry / microbiology), Change Control, audit (including CAPA Program), batch record review, product release, Audit (FDA / ISO 9000-2008), annual product review, Manufacturing Deviations/OOS Incidents/Root Cause Investigation/CAPA, Complaint Response, product recall, Gap Analysis, Establishment Inspection, both General and Pre-Approval - PAI] and regulatory affairs operations with a proven ability to communicate with the domestic (US-FDA-CDER/CBER/CDRH, USDA, DEA, EPA and OSHA) and international (MHRA / EMA) regulatory agencies.PROFESSIONAL SKILLS AND ACCOMPLISHMENTS:1.0 Quality (QA/QC) and GxP Compliance Operations Clinical Stage and Commercial Products:1.1 Development, Execution and Documentation of a multi-plant global Quality (QC/QA) strategy and tactics in consultation with the upper management and its implementation at all levels of operations for drug (Both API and Finished Dosages - Solid / Semi-solid, Oral Liquid, Ophthalmic and Aseptically-Filled Sterile Liquid and Lyophilized) and biologic products,1.2 Establishing specifications (alert / action levels) for raw materials, non-chemical components (closure / container), labeling / packaging materials, and in-process / finished products,1.3 Establishing contacts with vendors directly and in liaison with material management personnel for procuring raw materials (chemical/non chemical components), equipment, and other critical items within the set QC/QA specifications for manufacturing products (both Clinical Stage and Commercial Products) with "Quality Built" design,1.4 Auditing / GAP Analysis of in-house manufacturing and laboratory operations, vendors, contract manufacturing / contract testing (CROs) facilities for the compliance of their operations to the FDA's / ICH /ISO 9000 / 13485, cGMP, GLP, and GCP regulations guidelines, preparation of audit reports for the upper management, including outlining deficiencies and recommendation for corrective (CAPA) actions,1.5 Management of QC (Chemistry / Microbiology) laboratory operations,RESUME OF Candidate's Name , RAC, M.BIRA., CONTINUED1.6 Development and implementation of stability testing programs for currently marketed and new bulk and finished products in compliance with the FDA / ICH stability guidelines,1.7 Management of FDA / DEA Remedial Program (Successful Resolution of FORM FDA483 / Warning Letters / Consent Decree Observations) in Close Liaison with the FDA,1.8 Development and implementation of documentation system, including Master Production and Control Records, Standard Operating Procedures, Standard Control Procedures, Document Change Control Notice,1.9 Co-ordinating and directing multi-disciplinary activities for FDA approval of manufacturing facilities for sterile products, including validation of HVAC / WFI / Purified Water Systems, Blending, Tabletting/Encapsulation, Coating, Autoclaves, Ovens / Tunnels, Compounding, Filter-Sterilization, Aseptic-Fill, and Labeling / Packaging operations,1.10 Development and Implementation of FDA's cGMP and GLP (FDAs 21 CFR Part 50, 54, 56, 58, 210/211, 600) training programs for manufacturing and laboratory personnel,1.11 Initiation and implementation of all activities pro-actively to prepare the Chemistry, Manufacturing and Control (CMC) Section of all regulatory submissions,1.12 Development, execution, and documentation of tailor-made protocols for validation (including calibration) of systems (WFI / Purified Water System, HVAC System, Preservative Challenge System, and Cleaning System), equipment, manufacturing processes, and analytical methods, and1.13 Development and implementation of product complaint and product recall operations.2.0 Administrative / Management Operations:2.1 Hiring of support staff (professional and secretarial) personnel,2.2 Training, and effective supervision and motivation of support staff personnel,2.3 Annual performance evaluation of support staff personnel,2.4 Budgetary control for the personnel and capital expenditure, and2.5 Presentation of QC/QA and Regulatory Affairs/Compliance programs to Potential Investors.RESUME OF Candidate's Name , RAC, M.BIRA., CONTINUEDPROFESSIONAL EXPERIENCE:Current Position: Since April 2004President / Senior Consultant Global QA/QC/Compliance/FDA Liaison OperationsSNK Global Consulting ServicesBay Shore, New York 11706Setting-up tailor-made consulting services - Global Quality (QA/QC), Regulatory Affairs, Compliance cGMP, GLP, GCP/ICH, Internal Audit (GAP Analysis), Vendors/ CMO/CRO/Contract Testing Laboratory Audits, Facility Qualification and Validation, CAPA,Change Control, Manufacturing Deviations / OOS Incidents, Root Cause Investigation, Liaison with Client Organizations and US-FDA (including FDA Remedial Programs) and otherinternational (Canada, Australia, England, Europe, Ireland, South America) regulatory agencies and Documentation Control Systems for Pharmaceutical and Biopharmaceutical Industries.October 1996 March 2004Vice President of Quality (QA/QC), Regulatory Affairs and Compliance OperationsTime-Cap Labs, Inc.Farmingdale, New York 11735Responsible to President for the staff of twenty (20) professional personnel for the regulatory affairs (both compliance and submission), quality assurance, and quality control operations for solid oral dosages, capsules and tablets, both for immediate and sustained release, label development and review, documentation system, FDA / DEA interaction, and direct customer liaison.May 1996 to October 1996Senior Manager, International Regulatory Affairs / ComplianceRoberts Pharmaceutical CorporationEatontown, New Jersey 07724Responsible to Vice President, Worldwide Regulatory Affairs for the international registration (submission and compliance operations) of drug and biologic products, in liaison with the FDA, brokers / distributors and international regulatory agency personnel.February 1995 to March 1996Director, Quality Assurance, Quality Control and Regulatory AffairsGraham Chemical CompanyJamaica, New York 11434Responsible to the General Manager for the quality assurance, quality control, regulatory affairs, validation, cGMP training, audit and documentation control operations for the drug (parenteral) products and an active interaction with the state and federal agency personnel during "on-site" regulatory inspection and follow-up post-inspectional activities.RESUME OF Candidate's Name , RAC, M.BIRA., CONTINUEDMarch 1994 to January 1995Director of Regulatory Affairs / ComplianceImmuno-U.S., Inc.Rochester, Michigan 48307Responsible to Vice President, Operations / Responsible Head for direction of multi-disciplinary activities for regulatory submissions of PLA's / ELA's / Amendments / Labeling / Promotional Materials, compliance, documentation control, and validation of manufacturing operations for biologic products, and active liaison with the FDA (CBER / District) and USDA personnel during "on-site" establishment inspections and follow-up post-inspectional activities.June 1989 to March 1994Regulatory Affairs /Quality Assurance ManagerMelville Biologics Division / New York Blood center, Inc.Melville, New York 11747Responsible to Vice President, Scientific Affairs / Responsible Head for managing quality assurance, validation, change control, cGMP training, audit, documentation system control, regulatory affairs and regulatory compliance operations for biologics and device products for both domestic and international markets. Development and implementation of regulatory strategy for new products, regulatory support for the currently-licensed products, "Hands-on" experience to initiate, co-ordinate and complete PLA's / ELA's / 510k applications, training and supervision of support (technical and secretarial) staff, managing of establishment inspections and active liaison with the FDA / CBER and district office personnel.November 1988 to May 1989Regulatory Affairs SpecialistKendall McGraw PharmaceuticalsIrvine, CA 92718Responsible for coordinating multi-disciplinary activities for approval of new generic drugs (ANDA's), quality compliance, documentation control, batch records review, audit and FDA approval of the manufacturing facility.February 1984 to October 1988Director of QA and Regulatory ComplianceAdvance Biofactures CorporationLynbrook, New York 11563Responsible to Executive Vice President for the quality assurance, documentation control system, batch record review and release, audit, complaint response, audit and regulatory affairs/ compliance functions for drug (NDA) and biological (PLA / ELA) products, and regulatory review of clinical protocols of drug and biological products in human (Phase I through III studies), and an interaction with FDA (CBER / District) personnel.RESUME OF Candidate's Name , RAC, M.BIRA., CONTINUEDFebruary 1981 to January 1984Manager, Microbiological ServicesByk-Gulden (Altana), Inc.Melville, New York 11747Responsible for the quality control, quality assurance, audit, validation, documentation system control and product development functions for drug and device products. In addition, I assisted in the collation, organization, and review of support data for submissions (ANDA's / NDA) to FDA and Liaison with FDA.November 1978 to July 1980Manager, Research and DevelopmentOxoid Laboratories LimitedBasingstoke, Hampshire, United KingdomResponsible for a multi-disciplinary team of fifteen (15) people (8-Microbiology, 3-Chemistry, and 3-Immunology) for improvement of the currently existing and development of new microbiological diagnostic products.April 1973 to October 1978Head, Microbiological SectionDepartment of Microbiology and Cell BiologyHuntingdon Research CenterHuntingdon, Cambridgeshire, United KingdomResponsible for planning, supervision, and coordination of multi-disciplinary projects for pre-clinical In-Vitro and In-Vivo studies and clinical studies in human for new drug products, preparation of cGMP training programs for production personnel, documentation, validation protocols, and quality control / quality assurance programs for clients from the drug, device, diagnostics. foods and cosmetic products organizations. In addition, also responsible for project cost estimate and client liaison.December 1966 to March 1973Worked as a microbiologist in increasingly responsible positions with Aspro-Nicholas (Schering), Bristol-Myers, and Squibb Corporations in the United Kingdom.Responsibilities included routine quality control testing for drug, foods and cosmetic products cGMP training, development of protocols for screening for new / improved anti-microbiological products (Drugs / Sanitizers / Disinfectants), analytical method development, preservative efficacy testing and clinical testing of drug products in human.July 1963 to September 1966Worked as a microbiologist in clinical, dairy, and drug (Squibb) organizations in India.Responsibilities included setting-up tests for diagnosis of microbial diseases, sensitivity tests, routine pathology, dairy hygiene, and quality control testing of drug products, environmental monitoring of production areas, and conducting pilot-scale production of an enzyme, Penicillinase.RESUME OF Candidate's Name , RAC, M.BIRA., CONTINUEDPROFESSIONAL AFFILIATIONS:1.0 Member, British Institute of Regulatory Affairs, London, United Kingdom;2.0 Member, European Society of Regulatory Affairs, London, United Kingdom;3.0 Member, Institute of Biology, London, United Kingdom.EDUCATION:1.0 B.Sc. Degree, Microbiology and Chemistry, University of Bombay, India (1963);2.0 M. I. Biol., Chartered Biologist, the Institute of Biology, London, United Kingdom (1975);3.0 Regulatory Affairs Certified - R.A.C. by Regulatory Affairs Certification Board, USA (1992);4.0 M. BIRA., Elected by the Governing Body of the British Institute of Regulatory Affairs (1994).PERSONAL:Citizenship: United States of America (1993) |
