NIRMAL DUBEY - d.doc

Omam Consultants Services, AhmedabadCurriculum vitaeCurriculum vitaeNIRMAL K. DUBEY Position : Quality Control Head ( Formulation Unit)Educational Qualification: M.Sc. (Organic Chemistry)Professional Experience : 8 Years in Pharmaceuticals FormulationCompany Profile:1) Presently working with Alkem Group of Companies ( Indchemie Health specialities), as an Manager: QC . The manufacturing site is approved by WHO. 2. Oct 2005 to July.2006 working with Serum Institute of India Ltd; Pune, as an Assistant Manager: QC (ANDA Project _ Injactables). WHO and other regulatory affairs approve the Manufacturing side. 3) Sept 2004 to Oct.2005: Worked with Glenmark Pharmaceuticals Limited, Colvale-Goa, as an Executive -QC/QA (ANDA Project) for Tablets, Capsules and Ointment.Manufacturing site is approved by USFDA, TPD-Canada, ANVISSA -Brazil, MCC-South Africa, FDA-Ethiopia FDA-Nigeria and WHO.4) July 2003 to Sept.2004: worked with M/S Sun Pharmaceuticals Ind. Ltd (Formally known as M.J.Pharmaceuticals Limited) Halol, Gujarat as an Sr.Officer -: Validation (ANDA Projects). Manufacturing site approved by USFDA,MHRA-UK,ANVISSA-Brazil, MCC-SA5) Nov, 1999 to March, 2003: worked with Ipca Laboratories Limited, Athal, Silvassa, as an Officer in Quality Control Dept. The tablet manufacturing facility at this location Is approved by MCA-UK, MCA-Zimbabwe, MCC-South Africa, TGA-Australia, WHO and Germany Drug Administration. The sterile product facility is approved by MCC-South Africa & ISO-9001 Certification by SGS. Audit Exposure: USFDA, MHRA-UK, MCC-SOUTH AFRICA, MCA-ZIMBZBWE, TGA-AUSTRALIA, ANVISSA-BRAZIL, WHO-GMP, ISO-9001 BY SGS, GERMANY DRUG ADMINISTRATION and TPD-Canada etc.Career Objective: An Adaptable, Enthusiastic and self-motivated individual willing to be leader of dynamic team to achieving the challenging goals.To have a challenging career in the Quality Control/Quality Assurance department for US, EU, Brazil , Australia , South Africa ,Brazil , Canada market , with a reputed Pharmaceutical formulation Organization .HIGHLIGHTS Over 8 years of experience in working in Quality Control/Quality Assurance for regulatory and semi regulatory markets. Skilled in usage of analytical instruments (HPLC, UV, IR, GC etc.) Hands on training in operation, calibration and troubleshooting of various laboratory instruments/equipment. Well versed in cGMP as per ISO-9001, MCC, MHRA , ANVISA , TPD ,TGA AND USFDA Requirements. Focused, goal oriented quick learner and a flexible team player. Computer knowledge of analytical software and knowledge in SAP software. Manage all resources like reagent, chemicals, solvents, reference standard and instruments for QC labs as per the requirement. Heading of all activities for raw materials, finished product, and packaging materials. Microbiology, stability studies and method development sections. Developed and validate all the method which is used in product analysis. Developed and validate stability indicating method for impurity profile for stability studies.Documentation Prepared and approval of General SOPs and SOPs for operation and Calibration Procedure for UV, HPLC, FT-IR, GC, KF etc., Tap density etc., Batch Releasing and Investigation of OOS. Involving in the Regulatory work, i.e. ANDA submission and compliance for finished dosage forms. Batch Deviation approval. Actively participated for Cleaning Validation. Interpreted results from raw data and generated reports. Preparation of Specifications and Method of Analysis for Raw Materials and Finished products. Periodical review and revision of all Documents. Compliance Performed work in compliance with cGMP, ISO-9001, MCC, MHRA , ANVISA , TPD ,TGA AND USFDA Accreditation. Performed work in compliance with ISO-9001, MCC, MHRA , ANVISA , TPD ,TGA AND USFDA Accreditation. Designing and setting up the Quality Systems. Conduct Quality Assurance audits / self inspections Preparation and approval of SOPs Vendor Approval. Reviewing authority for specification of equipments, instruments, systems to be procured. Reviewing authority for Analytical Method Validation Documents. Training on cGMP and other Issues.Validation: In charge validation department and responsible for supervising, monitoring and ensuring all the matters related to Analytical Method validation. Reviewing Authority for method validation and its Documents. Preparation of Master validation plan. Preparation, execution and certification of Equipment Qualification protocols (IQ, OQ, PQ) for the equipment .Ensuring Approval & Certification of all the validation Documents. Review of qualification Documents. Interaction with External Consultant. Heading the Regulation Inspection/ External Audits.Regulatory Affairs: Total Quality Management of Formulations including ISO-9001, MCC, MHRA , ANVISA , TPD ,TGA AND USFDA Accreditation. Audit Team Leader of ISO-9001, MCC, MHRA , ANVISA , TPD ,TGA AND USFDA for Internal Audit. Upgrading the systems, procedures & Documentation to meet the Requirement of USFDA, MHRA and MCC for Formulations. Preparation for internal Inspection report and compliance for external bodies.To manage the innovator (RLD) for ANDA project and producing equivalency data against with product which are going to registered in USA and EU markets.To co-operate with regulatory affairs department for technical issues and documentation for ANDA, as per requirements.My major job profiles are reviewing of Analytical documents (ANDA PROJECT submission) as per regulatory requirements for Example Specifications, Standard test procedure, Certificate of analysis for finished product, active and inactive ingredients, Innovator related documents, working standard COA along with protocol, Packaging materials specification and COA along with vendor COA and HPLC Chromatograms and IR Spectrum. Final document submitted to HO Regulatory for Submission in US.Reviewing of HPLC Calibration record, Stability studies protocol and data and Analytical Method Validation protocol and report (Finished product and API, (ANDA-product).GLPs Compliance in Analytical Laboratory and Training.* Validation : Software validation for HPLC,GC , UV and IR as per 21 CFR Part 11 requirement, Excel Spread Sheet Validation as per FDA-GLP requirement* Analytical Method Validation: (ANDA Projects)v Cleaning method validation (Rinse and swab method validation) and Analytical (Assay, Related substances, Degradation, Dissolution Preservative content method validation) and Process Validation and Stability studies. Preparation of Analytical method validation protocol (Assay, Dissolution, Related substances, Chromatographic purity, preservative contents) and Impurities Profile.Preparation of Cleaning method validation protocol & Report (rinses and swab) and performs analysis on HPLC.Checking of Analytical Method validation protocol and reports. Preparation of stability studies protocol and data sheet as per ICH guidelines.Preparation of HPLC Software validation protocol and report as per 21CFR Guidelines.Analysis on HPLC with different make such as Simadzu, Waters, Agilant, TSP, Merck.Preparation of Justification and investigation report if any deviation like repeats analysis, RSD problems, instrument failure etc.Pharma equivalence study of Innovator and comparison study with in-house samples. And preparing report and COA as per USFDA requirement.Preparation of HPLC software Validation and IQ, OQ, PQ of Instrument protocol.Preparation of OOS Investigation report and Analysis.Conversant with maintenance, regeneration and efficiency of HPLC columns and chromatographic troubleshooting. Management Of Reference standard and Working standard as per requirements. Finished Product: (Bio-equivalence study) To perform analysis of Innovators and in-house sample as per specification. Preparation of Bio-equivalence study report and certificate of analysis.To carry out in-vitro dissolution analysis of innovator Vs In-House product and prepared the report as per FDA requirements To prepare and review the analytical document before submitted to FDA Final checking of equivalency reports & COA before submission of ANDA projects. * Stability studies: (ANDA Projects)To maintain the list of monthly sample for analysis at various temperature.To check and maintain accelerated, intermediate & long term conditioning oven for Temperature & humidity.To maintain HPLC logbook for stability sample. To manage the analysis of stability samples as per specification & stability indicating method.To prepare and approval of protocol for stability studies product.To reviewed the updated summary report of all the products, which is kept in stability studies. To correspond with CQD/Export for stability studies report for registration of new product in regulatory market. * Packaging material: Review and preparation of Packaging material specification and Test procedure.* Raw material: Manage and monitored all the activity as per regulatory requirement and day to day planning, troubleshooting and commu