KANUBHAI M. DHORAJIYA
Email : k_dhorajiya AT yahoo.co.in
OBJECTVE :
Want to utilize my experience in managing and directing production process to increase the QUALITY ANDoutput efficiency of the organization through optimum utilization of resources.
PROFESSIONAL QUALIFICATION :
EXPERIENCE :
** M. Sc. (Chemistry) with first class, from NIMS University.
** At present I am working in Denis chem lab Ltd, Ahmedabad as Assistant General Manager Production from March 2019.
** I have working in Ashish Life science Pvt. Ltd., Boisar as a Senior Manager Production from Jan. 2018 to February 2019 (Small volume parenteral).
** I have working as Deputy General Manager(Operation) in Venus Remedies Limited Baddi from Nov. 2011 to Dec. 2017 [EU GMP, Latin American GMP (INVIMA), Ukraine GMP, TGA and Columbian GMPapproved facility (Dry sterile powder – Penem & Cefalosporin group, Oncology – Lypholised and liquid injectable, PFS and General Ampoule and vial injectable)].
** I have working as Asst. Production Manager in Marck Bioscience Ltd. Ahmedabadfrom May 2010 to Nov. 2011 [ANVISA (Brazil) approved facility (SVP injectable and ophthalmic product with FFS technology)].
** I have working as Asst. Production Manager in Unique Pharmaceuticals Laboratories (A division of J.B. Chemicals & Pharmaceuticals Ltd.), Panoli from March 2007 to May 2010. [MCC (South Africa) and ANVISA (Brazil) approved facility (SVP with glass ampoule and vial injectable)].
** I have working as a Production Executive in Khandelwal Laboratories Pvt. Ltd. Dadra from June 2006 to March 2007 in Small Volume Parenteral (Ampoule & Vials).
** I have working as a Senior Production officer in Umedica Laboratories Pvt. Ltd. Vapi from September 2000 to June 2006 in Small Volume Parenteral (Ampoules, Vials and Sterile Non Beta lactum and Beta lactum Dry Powder).
** I have working as a Production officer in Magna Laboratories Pvt. Ltd. Vapi from March 1998 to September 2000 in Small Volume Parenteral (Ampoule & Vials).
EXPOSURE :
** I have working as a Production chemist in Core Healthcare Ltd. Rajpur from January 1992 to March 1998 in Large Volume Parenteral (FFS Technology).
** Small volume parenterals(Glass Ampoules & Vials, Dry sterile powder (ß-lactum (Penicillin and Cephalosporin group) and Non ß-lactum), Oncology, Contrast media, Anti-biotic and pain killer.
** Knowledge of Latest technology equipment like Vial washing, sterilizing Tunnel and Vial filling machine (Bosch- Germany).
** Visual inspection- Automatic Visual Inspection machine – Brevetti- Italy.
** Ophthalmic product and dilution with FFS technology.
EQUIPMENT HANDLING :
** Large Volume parenterals(FFS technology – IV fluids).
** Ampoule washing m/c – Kembert. United eng and Fabtec Eng.
** Vial washing m/c – Bosch, Luxmi eng, EL and BEE eng, SP eng.
** Sterilizing Tunnel – Bosch, Klenzaid, Fabtec, Kembert
** Ampoule filling m/c – Kembert. Petals, United eng and Fabtec
** Vial filling m/c – Bosch - Germany, Luxmi eng
** FFS filling m/c – Rommelag 304 and 3012M-Germany
** Steam sterilizer – Metal chem, Pharma lab, Machin Fabric
** Super heated water spray sterilizer – Getinge-Germany, Machin Fabric and Pharma lab
** Pre filled syringe filling m/c – Hari Krishna Eng.
** Dry sterile powder filling m/c – Ambica, NK pharma and Vikram eng.
** Vial Sealing m/c – Ambica, NK Pharma, Vikram Eng and United eng.
** Muli column for WFI preparation – Kothari eng, Pharma lab, Metal chem and Machin Fabric.
INSPECTION FACED :
Visual inspection m/c- – Brevetti- Italy.
JOB PROFILE :
** EU GMP, WHO, MCC, ANVISA (Brazil), Ukraine GMP, ANVIMA (Columbia).
** Overall responsibilities of operation department.
** Prepare and review the instructions required for manufacturing drug product.
** Implement the manufacturing related process.
** Implement and revision the standard operating procedures authorized by CQA across all the manufacturing areas in the plant.
** Ensure the production deviations are reported, evaluated, investigated and the conclusions are recorded.
** Implement and set the highest standards of quality as per the pharmacopoeia and guideline.
** Ensure timely calibration, validation and preventive maintenance of equipment.
** Participate in qualification of the modified facilities or equipments as and when applicable.
** Ensure and maintain environmental conditions of sterile area.
** Achieve the quantitative and qualitative targets of manufacturing.
** Ensure the implementation of CGMP and all such international standards, where by the plant is certified to facilitate the export in regulated and non-regulated markets.
** Participant and complies internal and external regulatory audits as their norms.
** Ensure the only authorized personnel of respective areas signs all documents related to their area.
** Guide and help people in implementing cGMP at plants.
** Train department personnel and to participate in annual product reviews.
** Periodically review the plant activities and suggest the corrective actions for the manufacturing and administrative system.
** Provide solutions to the administrative issues.
** Reporting to Chief executive officer.
** Monitor the Raw material and packing material requirements and its co-ordination with purchase and inventory department.
** Check and maintain the documentation and also plan v/s actual production report.
** Maintain discipline in the department.
** Monitoring of manpower requirement, utilization and quality output of the department.
** Monitoring of manufacturing yield and inventory control of department.
** Co-ordinate with outside party for the development work and maintenance work.
ACHIEVEMENTS :
** Training of “National Service Scheme” activity and I was awarded for meritorious performance and dedicated service during the year 1989-90.
** Training of “Capsule course in Pharmacy” and I was awarded for Excellent performance during the year 1993.
** Training of “Advance Training Programme” and I was awarded for Excellent performance during the year 1994.
** Training of “ISO-9000” & “C.G.M.P.”
** Training of computer and knowledge of SAP and ERP System.
** I am FDCA approved in parenteral mfg.
section from Gujarat state.
PERSONAL DETAILS :
Age : 52 Years
Nationality : Indian
Language Known : Gujarati, Hindi & English
DECLARATION :
I hereby declare that all the information in my Curriculum-Vitae is true to the best of my belief and knowledge.
DATE :
PLACE :