Sr. Executive - Production
Resume:
BHADRESH BHAVSAR Phone : 91-79-267*****
Mobile : 099********
Email : **********@*******.***
**, ***** *******, ****** ********* Complex, Premchand Nagar Road, Satellite,
Ahmedabad-380015, Gujarat, INDIA.
OBJECTIVE Seeking a Higher Management Position for Production in Pharmaceutical.
PROFESSIONAL
EXPERIENCE At present, From 21st Jul 2007, Working With Cadila Health Care Limited, Well Known As ‘ ZYDUS ‘, Ahmedabad, Gujarat, INDIA. As Senior Executive- Production.
(‘ZYDUS ‘Cadila Healthcare Ltd. Is the company engaged in manufacturing of Various type of formulations, R & D, Bulk drugs, Vaccines and also having facility of Clinical Studies and having good market value world wide.
Senior Executive: (Presently managing Loan License manufacturing facility for Form Fill Seal ( SVP and LVP ) Products on behalf of Company.
Responsibilities:
• Perform Quality audit as per schedule-M- GMP norms prior to finalize contract for third party & L/L manufacturing.
• Proceed to apply and check necessary Regulatory certificates and license prior to conduct production of new product or a formulation.
• Plan and discuss for Production planning, Scheduling, and Inventory controls as per required production Target.
• Follow GMP and FDA rules and review Master Formula Record, SOPs, Validation records and other records and maintain them in timely manner and make necessary changes and update them periodically as per rules.
• Ensuring the authentication of whole process by Process validation Method.
• Manage Contract Manufacturing Sites as per planning for scheduled batches and manage inventory.
• Manage batch schedule as per planning and verify per master Batch record
• Verify active ingredients ( APIs) and inactive components at the time of compounding the materials.
• Check records for Process and verify with master records, specification and SOP and authenticate them.
• Check sanitation and cleaning process after completion of batch as per cleaning SOP for each machineries and verify records for same and authenticate.
• Assure entire production of a product to follow the regulatory procedure followed by QC and QA approval for releasing the product before conduct next step of packaging.
• Manage all the packing activities and verify every steps as per SOP and GMP procedures.
• Confirm the approval of QC and QA department prior to release the packed product for sale in the market.
• Ensure entire process by verify checklist and all necessary documentations by authenticate them.
• Check and verify site maintenance, Building Maintenance and Sanitation procedure as per GMP guideline and authenticate the records for the same periodically.
25th July 2006 to 20th Jul 2007, as Production Manager with Hiran Orgochem Limited, Mumbai, Maharashtra, INDIA.
(Hiran Orgochem Ltd. Is the company engaged in manufacturing of Bulk drugs having turnover of Rs.400 crore per annum and also having Certifications and licenses like, ISO-9002 and WHO-GMP. Now entering in formulation products manufacturing since one year.)
Production Manager.
(
Responsibilities:
• Perform Quality audit as per schedule-M- GMP norms prior to finalize contract for third party manufacturing and report to V.P.
• Proceed to apply and check necessary Regulatory certificates and license prior to conduct production of new product or a formulation.
• Plan and discuss for Production planning, Scheduling, and Inventory controls as per required production Target.
• Follow GMP and FDA rules and review Master Formula Record, SOPs, Validation records and other records and maintain them in timely manner and make necessary changes and update them periodically as per rules.
• Ensuring the authentication of whole process by Process validation Method.
• Manage Contract Manufacturing Sites as per planning for scheduled batches and manage inventory.
• Manage batch schedule as per planning and verify per master Batch record
• Verify active ingredients (APIs) and inactive components at the time of compounding the materials.
• Check records for Process and verify with master records, specification and SOP and authenticate them.
• Check sanitation and cleaning process after completion of batch as per cleaning SOP for each machineries and verify records for same and authenticate.
• Assure entire production of a product to follow the regulatory procedure followed by QC and QA approval for releasing the product before conduct next step of packaging.
• Manage all the packing activities and verify every step as per SOP and GMP procedures.
• Confirm the approval of QC and QA department prior to release the packed product for sale in the market.
• Ensure entire process by verify checklist and all necessary documentations by authenticate them.
• Train every personnel for desired process and perform tests for personnel qualification procedure periodically as per GMP rules.
• Perform and verify operations of each machine used in the production for capacity, performance, and maintenance verification for Operation qualification process as per GMP rules.
• Check and verify site maintenance, Building Maintenance and Sanitation procedure as per GMP guideline and authenticate the records for the same periodically.
10 November 2005 – 25th July 2006, Lincoln Pharmaceuticals Ltd., at Khatraj, Tal. Kalol, Dist. Gandhinagar, Gujarat, INDIA
(Lincoln pharmaceuticals Ltd. Is the company having Certifications and licenses like, ISO-9002, UKAS005, and WHO-GMP.)
Production Manager.
Responsibilities:
• Proceed to apply and check necessary Regulatory certificates and license prior to conduct production of new product or a formulation.
• Plan and discuss for Production planning, Scheduling, and Inventory controls as per required production Target.
• Follow GMP and FDA rules and review Master Formula Record, SOPs, and other records and maintain them in timely manner and make necessary changes and update them periodically as per rules.
• Ensuring the authentication of whole process by Process validation Method.
• Manage Contract Manufacturing Sites as per planning for scheduled batches and manage inventory like
• Manage batch schedule as per planning and verify per master Batch record
• Verify active ingredients ( APIs) and inactive components at the time of compounding the materials.
• Check records for Process and verify with master records, specification and SOP and authenticate them.
• Check sanitation and cleaning process after completion of batch as per cleaning SOP for each machineries and verify records for same and authenticate.
• Assure entire production of a product to follow the regulatory procedure followed by QC and QA approval for releasing the product before conduct next step of packaging.
• Manage all the packing activities and verify every steps as per SOP and GMP procedures.
• Confirm the approval of QC and QA department prior to release the packed product for sale in the market.
• Ensure entire process by verify checklist and all necessary documentations by authenticate them.
• Train every personnel for desired process and perform tests for personnel qualification procedure periodically as per GMP rules.
• Perform and verify operations of each machine used in the production for capacity, performance, and maintenance verification for Operation qualification process as per GMP rules.
• Check and verify site maintenance, Building Maintenance and Sanitation procedure as per GMP guideline and authenticate the records for the same periodically.
1st September 1992 – 9th November 2005, Manas Pharma Mfg. Ahmedabad, Gujarat, INDIA (Sister concern of LA Pharmaceuticals, Vatva, Ahmedabad.)
Production Executive In Tablet and Capsule Section.
F.D.A. Approved Supervisory Chemist in Tablet Section.
Responsibilities:
• Follow GMP and FDA rules and review Master Formula Record, SOPs, and other records and maintain them in timely manner and make necessary changes and update them periodically as per rules.
• Plan and discuss for Production planning, Scheduling, and inventory controls as per required production Target.
• Prepare batch as schedule planning as per master Batch record. Supervise and verify active ingredients (APIs) and inactive components at the time of compounding the materials.
• Keep proper records and supervisions for Blending, Granulating, Drying, Lubrication, Compression, and if necessary, Coating process with proper documentation as per SOP with in-process records.
• Maintain sanitation and cleaning process after completion of batch as per cleaning SOP for each machineries and maintain records for same.
• Receive and handle raw materials and packing materials as per GMP rules like receiving, proper storage with proper identity, and sending for testing to Quality Control.
• Test request for product to Quality Control department like as in process test, finished product test report. Supervise and maintain in process, packing, finished product records.
• Follow the GMP rules trough whole process. Maintain SOP and make changes periodically as per rules. Maintain validation records for each machine used in production.
July 1987 – December 1991, Troikka Laboratories, Ahmedabad, Gujarat, INDIA
Assistant Chemist in Tablet Section
Responsibilities:
• Received raw materials and packing materials and quarantined them under test area after physical verification. Drew samples and sent for testing with test request form. Label them identically as ‘Under Test’ tag while test release report and stored material with proper identity with ‘Control Release’ label at proper storage area. Maintain raw material and packing material record.
• Issued raw material and packing material as per batch requisition from manufacturing chemist and maintain records for issuing of material.
• Supervise Blending, Granulation, Drying, Lubrication, Compression, and Coating process as per master formula and maintain in-process record as per FDA rules in prescribed forms.
• Sent samples for in-process testing for bulk product and store bulk product in quarantine while test report confirmed the product could release for further process. Sent bulk product for packing department and supervise all the packing activity with proper records. Follow the sanitation and cleaning process as per Standard Operating Procedure (SOP) and prepared all equipments for next batch. Maintain inventory records and keep control for raw materials and packing materials.
EDUCATION Bachelor of Science Major: Chemistry
Jun 1982 – Jun 1987 From Gujarat University, Ahmedabad, Gujarat, INDIA.
Diploma In Computer Application with Fox Base Programming.
Jan 1993 – December 1993 From C.B.S. Computers, Ahmedabad, Gujarat, INDIA.
PROFESSIONAL CERTIFICATION AND TRAINING
Completed Training for Good Manufacturing Practices (GMP) and World Health Organization (WHO) Procedures for pharmaceuticals as “Cost Building Project” organized by National Institute of Pharmaceutical Education and Research (NIPER).
• Certificate for ‘Training on SAFETY for Industrial Executives’ from Baroda Productivity Council.
PROFESSIONAL MEMBERSHIP • Food and Drug Control Administration approval for supervisory chemist for Tablet and Capsules section.
• Authorize person to Central Excise Department (The Revenue Department of Government of India) for Manas Pharma Mfg.
EXTRA CURRICULAR ACTIVITIES • Up gradation of non-GMP plant into Schedule-M, GMP plant, as Discuss with management, Architect, and other consultants in view of requirement of area, AHU, machinery up-gradation ( non-GMP to GMP ), etc.
• Operate instruments like High Performance Liquid Chromatograph (Waters), Gas Chromatograph (Chemito), and Infra Red Spectrophotometer (Shimadzu), Ultraviolet Spectrophotometer (Shimadzu), Flame photometer, Dissolution Test Apparatus in Quality Control department to help the process of analysis and method development.
• Attended seminars about Good Manufacturing Practices, Validation and new techniques about High Performance Liquid Chromatograph, which were organized by companies like Waters Corporation, Agilent Technologies, and Perkin Elmer and discuss important points with management, and recommend necessary changes for production and Quality Control Department.
COMPUTER LITEREACY • Windows 95, MS Excel, MS Word, and Other packages, which were develop for special application for instruments like High Performance Liquid Chromatograph and Gas Chromatograph.
• Maintenance of computers hardware.
• PRESENTLY WORKING WITH ‘SAP ‘SYSTEM for MATERIAL MANGEMENT MODULE.
Bhadresh Bhavsar
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