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[QUOTE=Guest;175427][B]RESUME :[/B] VISHAL KUMAR MISHRA [B]E-mail [/B]:vishalkmishra AT rediffmail.com [B]CAREER OBJECTIVE [/B]: - To implement and ensure the all cGMP norms to keep organization in state of best compliance level of national and international regulatory requirements.To follow the management policies along with required updation in existing practices through awareness for quality at all levels by continuous improvement of technical skills. [B] PRESENTLY ENGAGED IN [/B]: - “M/s Cipla Ltd." Sikkim, as a Management Staff since 2nd June 2011 to till date. [B]WORKING EXPERIENCE (+ 5.8 years) [/B]:- - 2.9 years with J.B.CHEMICALS & PHARMACEUTICALS PVT. LTD. Daman, in both Production & Packing Department as a Production-Packing officer from August 2008 to May 2011. - 2.4 years with Gujarat Liqui Pharmacaps Pvt. Ltd., as a Production Pharmacist in Production Department from April 2006 to August 2008. [B] AUDITS FACED [/B]:- - Nigeria Audit at GLPL, Vadodara. - FDA inspection at JBCPL, Daman. - Internal audits at JBCPL, Daman. - TGA at JBCPL, Daman. - MCC at JBCPL, Daman. - WHO at Cipla, Sikkim. [B]Technical efficiency [/B]:- - To increase the productivity of good quality products, through time-management, planning and less changeover time. - Minimization of the probabilities of line clearance failures by providing training to the concerned about the critical points to be checked during line clearance, so as to avoid product mix-up at any stage. - In process checks including the challenging of interlocks and controls of the machines and the provided systems, so as to ensure their proper working. - Rejection control & analysis, to minimize the loss of packing materials. - Supervision of manufacturing and packing processes in the machineries like, Vibratory-Sifter, Multimill, Octagonal- Blender, Planetary mixer, Encapsulation machine, Sachet/pouch packing machines : PAKONA 92 TWIN, PAKONA AG90, Blister pack machines: EPI-2500, EPI-3000FB, EPI-3010PDA, BQS, Strip pack machines: Satellite Engineerings, Precision Gears & Marchesini. - Machine wise spare list preparation and ensuring availability in change-parts storage area. - Review of quality related issues in packing materials with suppliers. - Control of process deviations, on line rejection of packing materials. - Line clearance activity with supervision of area and equipment cleaning. - Stereo management i.e, order, procurement, storage & destruction of stereos. - Review & compliance of BMR, BPR, SOPs, log books and all other documents related to production and packing. - Batch packing reconciliation. - Product & equipment history record maintenance. - Machine log, temperature, RH and pressure differntial monitoring. - Electronic weigh balance & checkweigher daily verification & calibration. - First pack verification, raising of PRRF, packed stock inspection, reweighing of the packed shippers and their contents before their transfer to the BSR along with Daily Production Report. - Unit operation of machine and packing line. - Annual product review along with data collection of the batches being manufactured. - Training of machine operators & casual workers for awareness of product & process. - Calculations for active pharmaceutical ingredients and excipients i.e raw materials for the batches to be dispensed for the manufacturing processes of tablets, soft gelatin capsules and oral powders on the basis of data provided by quality control and work-order. - General cleaning & status labeling of manufacturing areas, primary packing cubicles, packing lines, staging area, charging area & packed stock inspection zone. - In process checks for soft gelatin capsule encapsulation, pouch/sachet filling, tablet granulation, compression and packing. - Break down rectification and co- ordination with maintenance department. - Fumigation arrangement and recording. - Calculation, dispensing, yeild reconcillation, EMRM & EMCM of primary and secondary packing materials. - Offline packing & printing planning, supervision and segregation of pre-printed packing materials for further packing activities. - Manpower handling and their work allocation as per the requirement. [B] EDUCATIONAL QUALIFICATION :[/B] - BACHELOR OF PHARMACEUTICAL SCIENCES from (Gayatri College of Pharmacy, Sambalpur, Orissa, securing 65.3% as aggregate marks in the year 2005-06. under BPUT. - 10+2 from Government Higher Secondary School, Haldibadi Chirimiri, Dist. KOREA (Chattisgarh), securing 50.2% of Marks under M.P.Board in the year 2001. - Xth from Kendriya Vidyalaya Chirimiri (CBSE BOARD) securing 50.2% of Marks in the year 1999.[/QUOTE]