Quality Data
Resume:
Resume
Mr.Kiran Prakashchand Bhandari
E-mail:******************@*****.*** *****************@*****.***
M: +91-899******* /+91-823*******
Seeking a challenging assignment in Quality Assurance in the pharmaceutical sector to utilize acquired expertise and deliver best-in-class results.
PROFESSIONAL SNAPSHOT:
●A Quality Assurance Professional with 15 + years of experience in Quality Control,Quality Assurance, Validation and different International Quality audits.
●Extensive experience with reputed Indian & Overseas manufacturers with a global presence like, Lupin research Park, Sun pharmaceutical Ltd., Ranbaxy Laboratories Ltd.,Sterling healthcare Ltd., USV Ltd.and Emcure pharmaceutical Ltd.
●Review of analytical data of Finished products,inprocess, stability products,raw material,water analysis,paking material,AMV,Tech transfer,reports, protocols.relesed in SAP,LIMS data review.
●Analysis of Tablets, capsules, suspension, Injectable and handled of Analytical Instruments in Quality Control.
●Played key role in global cGMP Compliance and successfully faced audits: WHO-Geneva, UK-MHRA, US-FDA, ANVISA, TGA-Australia, MCC-South Africa.
●managerial, relationship, management, interpersonal, communication & problem solving skills.
●Proven ability of working in dynamic environments with high degree of customer/ supplier interaction.
●Proven experience of identifying remedial, preventive and corrective QC solutions.
●Capability of working autonomously in a Quality driven organization.
●Result oriented achiever with excellent track record for identifying opportunities for accelerated growth.
PROFESSIONAL EXPERIENCE
Agio Pharmaceutical Ltd.,Pune
Assistant manager – Quality control, Aug 2019 to till date
Analyst Qualification, Calibration, Qualification of Instrument/Equipments, SOP, Column Management, Procurement and Capex, Preventive Maintenance, Computer system Validation, Audit compliance and Working standard activity.
Ensure planning and execution of all activity in GLP section.
Responsible for review of SOPs, GTPs, specification, Protocol for stability, Protocol of Analytical Method Validation/Transferred/verification and other non-routine activity.
Responsible for Approved and review of Calibration of Instrument/Equipments.
Responsible for Usage Decision for Calibration of Instrument/Equipments through SAP and review of preventive Maintenance through SAP.
Responsible for Investigation of non-conformities like deviations, out of specifications, out of trend, failures, Market complains etc. and derive appropriate Corrective and preventive actions.
Responsible for execution and review of software validation documents.
Laboratory maintenance, laboratory setup as per QC GMP compliance.
Responsible for Preventive Maintenance and AMC of Equipment and instrument.
Review of Temperature and Humidity record, Daily Monitoring Record, External Calibration Record, IQ, OQ, PQ record of instrument/Equipment.
Responsible for provide training on revised SOP, New SOP and CAPA.
Responsible for review of change control, deviation, CAPA, incident, Reprocess in QAMS.
Responsible for review of Effective Monitoring of CAPA.
Coordinate with RA for filling the requirements of various regulatory submissions.
Responsible for preparation of AMC/CMC PO.
Responsible for initiation of capex items.
Laboratory maintenance as per GLP complies.
Training of staff, To ensure 100% TNI throughout the year.
To perform internal audits as per schedule.
Emcure Pharmaceuticals Ltd.,Pune
Executive – Quality Assurance sterile product devision, Apr. 2014 to Jul 2019
●All generated analytical datas doing review like Instrumental electronic data,audit trial, analytical data, Finish product,inprocess,stability, raw material, AMV,tech transferred, validation reports, protocols, calibration of instrument, water activity and outside testing data and maintain it in data management system.
●LIMS data creation,revision, review and support for commercial products and AMV.
●Gxp computerized system data,CSV data review
●Lab event,OOS,OOT, has is investigated with quality frames.
●QMS document like deviations,change controls is handling .
●Data integrity activity for complies audit
●Raw material Section group leader, Implementation and maintenance of Quality Management System in Own Manufacturing Site with the current regulatory requirements.
●Daily Monitoring activity in Acetic acid and potassium permanganate consumption record, primary standards consumption records.
●Raw material daily sampling and analysis planning, Training and troubleshooting in analysis.
●Planning of sample sending to outside Lab. for analysis and also send method of analysis and follow up of them.
●Training on sop.
USV LTD, Daman
Sr.Executive – Quality Control, Feb. 2012 to Apr.2014
●GLP Section group leader, Implementation and maintenance of Quality Management System in Own Manufacturing Site with the current regulatory requirements.
●Daily Monitoring activity in core areas like temp monitoring, calibration status, working standard status,
●Calibration of instruments like, Balance, HPLC, UPLC, Ion exchange chromatography, IR, UV, PH-meter, Oven, Dissolutions, DT, RI etc.
●Schedules of calibration of all instruments, Schedules of AMC, IQ/PQ/OQ of new instrument.
●Handling of Change Control and Deviation.
●Review of all data, working standard preparation and review data
●Training given on cGMP.
●Monitoring AMC and lab activity.
●Preparation and review of SOP’s
●Lims record results and review
Sterling healthcare LTD, Talegoan Dabhade, Pune.
Sr.Executive – Quality Control, Jan. 2010 to Jan.2012
●Laboratory setup as per user and safty requirements.
●Raw material section group leader. Independently handled Quality Control functions.
●Raw material daily sampling and analysis planning, Training and troubleshooting in analysis.
●Document review and release through in ERP system.
●Preparation of documents like STP, SOP & GTP, Review, Submission.
●Planning of sample sending to outside Lab. for analysis and also send method of analysis and follow up of them.
●Critical Support Services Qualification & Validation (Water systems).
●New project Validation analysis, document summit to RA planning and troubleshooting in analysis.
●Review of Finish product, Stability, In-process, RLD, AMLD analysis reports.
●Vendor / Supplier Qualification & certification.
●Cost reduction and budgetary planning of QC activities.
●Maintain the approved supplier list
●Handling of Change Control, Deviation and Market Complaints.
RANBAXY Lab. Ltd Dewas.
Executive - Quality Control, Sep.2006 to Dec.2009.
●Finish product analysis of various dosage forms like, tablets, capsules, injections, and dry suspensions.
●Attaint Various Training program, data integrity
●Raw material analysis of Domestic, Expo and ANDA active, Inactive material. Water analysis of raw water,WFI,PW,Decontamination,Cleaning Validation of API.
●Volumetric solution preparation and standardization.
●Calibration of Analytical Balance, FTIR, UV, HPLC, Dissolution, Autotitrator, Refractive index, polarimeter, PH-meter, MP, Bulk density LOD Oven. Analytical method validation.
●Intermediate and in process analysis
●Handling the instrument like, FTIR, HPLC, GC, UV,Dissolution, Disintegration test apparatus, Hardness test apparatus, Autotitrator, Particle size analyzer, Bulk density, Bru. Viscosity, Refractive index, polourimeter, PH-meter, Colometer, Melting point, Halogen Moisture analyzer.
●SAP record results,COA and review
●Attaint to regulatory audits
Sun pharmaceutical Ltd. Halol
Quality Control Officer- Quality Control, Mar.2004 to Sep. 2006
● Raw material analysis of Domestic, Expo and ANDA active, Inactive material. Water analysis of raw water, WFI, PW, Decontamination,Cleaning Validation of API.
●Volumetric solution preparation and standardization.
● Calibration of Analytical Balance, FTIR, UV, HPLC, Dissolution, Autotitrator, Refractive index, polarimeter, PH-meter, MP, Bulk density LOD Oven. Analytical method validation.
●Intermediate and in process analysis.lims record results, COA
●Sampling and Labelling of Domestic, Expo. Active, Inactive, ANDA material.
●Handling the instrument like, FTIR, HPLC,AAS,AES UV, GC, Dissolution, Disintegration test apparatus, Hardness test apparatus, Autotitrator, Particle size analyzer, Bulk density, Bru. Viscosity, Refractive index, polourimeter, PH-meter, Colometer, Melting point, Halogen Moisture analyzer.
●Attaint to regulatory audits
EDUCATION
●M.B.A. ( project Management), Ulyanovsk state University,Russian federation, Mumbai Mar 2014 with 56% marks.
●Msc. (Chemistry), Bhoj University, Bhopal, Jan 2009 with 56% marks.
●Bsc. (Applied Analytical Tech.), Dept. Of chemistry, Pune university, May 2003 with 55% marks
●Bsc. (Chemistry), Dr.P.V.V.P.collage, Loni Pravara, Pune University, May 2002 with 52% marks.
IT SKILLS
●Well versed with MS Windows/ Office/Excel, Internet surfing and literature collection.
●Diploma in Computer applications and Networking, teaching
Other Information
● NCC ‘C’ Certificate holder, Scout, Best fires award.
PERSONAL PROFILE
●Date of Birth : 11/03/1979.
●Sex : Male
●Marital Status : Married
●Language Fluency : English, Hindi,Marathi and Marwadi
●Nationality/Race : Indian/Asian
●Leisure Activities : Reading, Internet surfing and Learning something new,Music
●Personal Strength : A good listener, Positive Attitude, Hard working, Logical thinking.
●Alternate email id : *****************@*****.***
●Alternate Cell No. : +91-823*******
●Permanent Address : A/36/1, Adarsha colony, road no.2, A2/507,
Tirupati campus Phase III,
Tingarenagar, Visharantwadi,
Pune-411015, Maharashtra
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