Curriculam Vitte :
Prashant Prakash Bhalerao.
78, AH-01,’Preeti’House
Thakrenagar, N2, Cidco
Aurangabad
Dist : Aurangabad, Maharashtra
Mobile No :-09168788981/09175691083
Email : 1) bprash81 AT gmail.com. 2) bprash81 AT rediffmail.com.
Professional Experience :
1) Wockhardt Ltd :-
Working as Senior Production Executive in Production Injection Department from 29th Sep 2014 to till date at Sez Shendra, Aurangabad, Dist-Aurangabad, Maharashtra-431001.
Company Profile :
MHRA approved Oral solid dosage form, HPRA approved liquid preparation, and WHO approved Injection facilityengaged in the manufacturing of OSD, Liquid preparations, Injection, Aerosol Products, also have a Research center and API facility.
Job Profile :-
Production related :
** Preparation and Submission of Daily Production Reports, yield improvement reports, Extra Manpower Utilization hours reports.
** Preparation and documentation of Insulin clear and Suspension range of products like Wosulin 3070, 5050, R, N with various strengths (40IU, 100IU, 200IU) .
** Reviewing Shop floor logbooks, BMR completeness, updation of PM of equipments, Cross functional teams trends, protocols, Employees training reports. SOP’s.
** Preparation and Finalization of Exhibit, Commercial,Placebo,export product’s batch manufacturing records.
** Control of empty & Filled vial rejections by Appling various scientific ways.
** Monthly, quarterly yearly Completion & Submission of Quality Records like, Log cards, Annexure to QA.
** Execution of Production planning & making Shift arrangements of officers, Technicians & workers
** To improve quality of process & equipment, training & motivation to subordinates & dept. workers
** Executing & Conducting Validation of Areas & Equipments as per VMP.
** Media filling Activities and their Documentation. Exposure to SAP system.
** Discussion & suggestion to Assist. Manager about Gap analysis so as to make smooth running of system, Up gradation ,saving manpower, material, machine utility.
QMS related :
** Take a Planned or Unplanned Deviation, Preparation and Finalization of deviations or OOS related Investigations reports.
** Through Tack wise system initiation and closure of Change control related to System modification, Process Improvement, Sop or BMR revisions.etc
** Involved in USFDA response related work.
Machines Handled :-
** Ampoule washing, Filling M/c (3&4 Head)(CADMAC).
** Vial Washing & depyrogenation (KLENZAIDS), Filling & Tray Loader M/C (BAUSE+STROBEN), HPHV or SOC Processor(Metal Chem. industries).
** Dry heat Sterilizer (ICOS), LOAD CELL (METTLER & TOLEDO) for manufacturing & filtration purpose.CIP/SIP System (PHARMALABS).
1) Torrent Pharmaceuticals Ltd :-
Working as Production Executive from 2011 year & in Parental department from 24th Nov 2006 to till date at Indrad, Tal-Kadi, Dist-Mehasana, Gujarat-382721.
Company profile : USFDA approved Formulation facilityengaged in the manufacturing of Tablets. Parental Products, Research center. NovoNordisk Insulin Preparation, Tunnel System, SAP System.API facility.
Job profile :-
** To Prepare & Submit Daily Production Reports, Manpower Utilization reports.
** Handling of Machine Capacity Utilization, production output ,shop floor activities, Cleaning & sanitization through production officers in Parenteral department.
** Preparation and documentation of Insulin Batches, stock solutions. Familiar with Filling, & Equipments Used/maintaining stock in Production. Day to Day troubleshooting on the shop floors
** Documentation, Preparation & Revision of SOP & protocols of validation as per cGMP requirements. Final Review of BMR Before handover to inspection.
** Control of empty & Filled vial rejections by Appling various scientific ways.
** Monthly, quarterly yearly Completion & Submission of Quality Records like, Log cards, Annexure to QA.
** Execution of Production planning & making Shift arrangements of officers, Technicians & workers
** To improve quality of process & equipment, training & motivation to subordinates & dept. workers
** Executing & Conducting Validation of Areas & Equipments as per VMP.
** Media filling Activities and their Documentation.
Exposure to SAP system.
** Discussion & suggestion to Assist. Manager about Gap analysis so as to make smooth running of system, Up gradation ,saving manpower, material, machine utility.
** To prepare investigation, Incident, deviation reports.
Machines handled :-
** Ampoule washing, Filling M/c (3&4 Head)(CADMAC).
** Vial Washing & depyrogenation (KLENZAIDS), Filling & Tray Loader M/C (BAUSE+STROBEN), HPHV or SOC Processor(Metal Chem. industries).
** Dry heat Sterilizer (ICOS), LOAD CELL (METTLER & TOLEDO) for manufacturing & filtration purpose.CIP/SIP System (PHARMALABS).
2) Aditi Pharmaceutical Ltd :
(Loan Licenses of CIPLA Pvt Ltd.)
Worked as Trainee Production officer in parenteral department from 23rd . July 2005 to16th Nov 2006 at Akkalkot Road MIDC, Solapur Maharashtra.
Company profile :- WHO-cGMP approved formulations facility engaged in the manufacturing of Form Fill Seal Products In Aqueous & Suspension Form For Eye/ear Drops,Lyophilised Preparation, Antibiotic Preparation, SVP Products, Liquid orals For Domestic & Export Purpose.
Job profile :-
** Handling shop floor activities in parenteral department.
** Knowledge of. Manufacturing, Filling, & Equipments Used In Production Activity.
** Manufacturing & Filling of SVP, oral solution, FFS & Lyophilized batches.
** Correction in SOPs & validation protocols as per shop floor requirements.
** Documentationof Filling of Batch production records & equipment usage logs.
** Production planning & training to subordinates & dept. workers.
** Requisition of Batch Manufacturing records (BMR).
** In process Quality control checks, Control on Yield of Batches.
** As per priority Scale up of new products manufacturing processes.
** Leak Testing & Terminal Sterilization of Products.
Machines handled :
** Ampoule washing, Filling M/c (3&4 Head)(CADMAC).
** Small volume Vial Washing & Filling Machine M/c.
** Rectangular Steam Sterilizer.
** Autoclave, Dry Heat Sterilizer.
** Semiautomatic Vial Washing & Filling Machine (KLENZAIDS)
** FFS Vial Leak Testing Machine.
3) CIPLA PVT LTD :-
Worked As A Cipla Co-Ordinator/Representive In Loan License Plant Of Cipla At Aditi Pharmaceuticals Solapur From 12th July 2004 To 11th July 2005.
Company profile :
Well KnownCompany engaged in the manufacturing of Form Fill Seal Products in Aqueous & Suspension Form for Eye/ear Drops, Lyophilized Preparation, Clear Vial Solution, SVP Products and Liquid orals.
Job profile :-
** Co-Ordination between Loan License Plant & Head Office at Mumbai.
** As Per Priority of Domestic & Export orders Plan the Production & Packing activity.
** Achieving The Target Quantity with Quality of Finished Product from Loan . License Plant, Follow up The Orders of Head Office.
** Making & Ruling Of The system throughout to the Loan License plant. ** Attending Meetings Of seniors At Head Office and Take Measure decision . . . About Any Changes in System/Plant.
Academic Qualification :-
** B.Pharma. from Shivaji University, Kolhapur, (Maharashtra).
Training received :-
** Current Good manufacturing practices (cGMP).21 CFR
** Workplace etiquette, Presentation Skill, Personality Development.
** GAP Analysis by G.L.Jain.
** In-house routine training conducted by company
Audits faced :-
** Local WHO. USFDA, MHRA ,HPRA (Pinnhood)Audits.
** National Drug Authority (Tanzania).
** Novo Nor disk (Denmark)
Computer knowledge :-
** Handled Windows, Ms-world, Excel, Power Point, Microsoft Office, Internet etc.
Languages known :-
** English, Hindi, Marathi.
Permanent address :-
78, AH-01, ‘Preeti’ House , Thakrenagar,N-2,Cidco, AURANGABAD Dist-Aurangabad. MAHARASHTRA
Personal profile :-
Name : Prashant P. Bhalerao.
Father’s name : Prakash C. Bhalerao.
Nationality : Indian.
Marital status : Married
Date of Birth : - 12 June 1981
Declaration :-
I hereby declare that all the above given information is true.
Date :-
Place :-
(Prashant P. Bhalerao)