Quality assurance, quality control
Resume:
Resume
Mr. Kiran Prakashchand Bhandari Mobile: +91-823******* / 899-***-****
E-Mail: ******************@*****.***/ *****************@*****.*** Seeking a challenging assignment of Quality Assurance in the pharmaceutical sector to utilize acquired expertise and best class results.
PROFESSIONAL SNAPSHOT:
● Diligent and result-oriented Quality Control, Quality Assurance, Professional with 17 + years of experience in reputed Pharma manufacturer like, Sun pharma, Ranbaxy Lab, Sterling healthcare Ltd.,USV Ltd, Emcure pharmaceutical Ltd, Agio pharma Ltd., and Shilpa Medicare Ltd.
● All-round competencies in quality control domain including all aspects covering – Training, Electronic Documentation, Quality Management System like Change control, Deviation, CAPA Management, Change controls, GAP Analysis.
● Document Software’s handled like Quantum ERP, SAP, DMS, EDMS, QAMS,e-Caliber known about LIMS etc.
● Optimum utilization of knowledge to achieve higher responsibilities & be an active team player in organizational objectives achievements
● Review of analytical data of finished products, in process, stability products, raw material, water analysis, packing material, AMV, Tech transfer, protocols, reports, released in SAP and LIMS data review.
● Analysis of Tablets, capsules, Ointments, 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 and UL-GMP, UL-Social audits.
● Excellent communication and interpersonal skills with strong analytical, team building management, problem-solving, investigation and organizational capabilities
● Internal Audit Management, Track wise related activities, Documentation Management and Document control, Training Management, GAP Analysis in Pharmaceutical Companies.
● Proven experience of identifying remedial, preventive and corrective QC solutions. Passes knowledge & expertise in cGMP, maturity of judgment under pressure/ ability to diagnose level of escalates problems without delay to appropriate levels for resolution.
● Capability of working autonomously in a Quality driven organization. The stints in diverse sectors have sharpened abilities in identifying potential, deconstructing complex situations and further conceiving and implementing streamlined solutions that have led to increased revenues, profitability and overall success.
● Result oriented achiever with excellent track record for identifying opportunities for accelerated. PROFESSIONAL EXPERIENCE:
Stantech Pharmaceuticals Pvt. Ltd. OSD, Lozenges Formulation, Ranjangaon Assistant manager –Quality control, Apr. 2024 to till date
● Responsible for overall quality functions. And execution of all GLP & non-routine activity related to Quality control as well as Microbiology department.
● Responsible for Analytical Method validation, Raw materials, Packing material & Finished Product samples release as per the SOP.
● Responsible for Preparation of AMV, Force degradation Protocol, reports, Specification, STP, COA.
● Summit the data to RA department for new dossier preparation
● Responsible for Procurements and maintenance of QC consumable & instruments.
● Responsible for preparing and review of Quality Management System documentation.
● Responsible for review of analytical documents, instrument audit trail.
● Responsible for Preparation, review and approval of Specifications & Standard Operating Procedure.
● Heading the QC departments for Internal & External audits Page 2 of 3
● Faced the UL-GMP, UL-Social audits and also provided the compliance of observations. Shilpa Medicare Ltd. Sterile injectable, OSD oncology Formulation, Unit IV Jadcherla Sr. Executive – Quality Assurance Compliance, May. 2021 to Feb. 2024
● Daily monitoring the quality control labs activity, Microbiology labs activity.
● Review of batch related data of quality control and microbiology labs and summited to third party consultant for release the batch, performed remediation activity to comply the data.
● CAPA effectiveness check through protocol and check list and compilation of third party and audit observation point with protocol base activity and risk assessment.
● All generated analytical data was review like Instrumental electronic data, audit trial of Finish product, in process, stability, raw material, AMV, reports, protocols, calibration of instrument, water activity, and outside testing data, risk assessments documents and maintain it in data management system.
● Lab event, OOS, OOT, was investigated and review with quality frames.
● QMS document like deviations, change controls is handling.
● Internal audits in quality control, microbiology lab, IT department regarding data integrity activity.
● Preparation of Departmental standard operating procedures (SOPs) and review of Cross functional Department (CFT) Standard Operating Procedures in Documents Management System (DMS) Software.
● Conduct the training as per schedule.
Agio Pharmaceutical Ltd., Formulation, Pune
Assistant manager –Quality control, May 2020 to 31 Mar 2021
● Analyst Qualification, Calibration, Qualification of Instrument/Equipment’s, SOP, Column Management, Procurement and Capex, Preventive Maintenance, Computer system Validation, audit compliance working standard activity 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, review of Effective Monitoring of CAPA and other non-routine activity.
● Responsible for Usage Decision for Calibration of Instrument/Equipment’s through SAP and review of preventive Maintenance through SAP.
● Responsible for Investigation of non-conformities like deviations, out of specifications, out of trend, failures, and derive appropriate Corrective and preventive actions.
● Laboratory maintenance, laboratory setup as per QC GMP compliance.
● Responsible for preparation of AMC/CMC PO. and Preventive Maintenance, 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 Coordinate with RA for filing the requirements of various regulatory submissions.
● Training of staff, To ensure 100% TNI throughout the year. Emcure Pharmaceuticals Ltd., Pune
Executive – Quality Assurance sterile product division, Apr. 2014 to Jul 2019
● All generated analytical data’s 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 activities protocol preparation and data review.
● Lab event, OOS, OOT, had investigated in quality frames.
● QMS document like deviations, change controls was handling.
● Raw material Section group leader, Implementation and maintenance of Quality Management System in Own Manufacturing Site with the current regulatory requirements.
● 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.
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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., calibration status, working standard status, Reference standard.
● 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 and Monitoring AMC of lab activity. Handling of Change Control and Deviation.
● Review of all data, SOP, COA, Glassware certificates, chemical certificates working standard preparation, protocol review, Lims record results review, Training given on cGMP. Sterling healthcare LTD, Talegoan Dabhade Pune.
Sr. Executive – Quality Control, Jan. 2010 to Jan.2012
● Raw material section group leader. Independently handled Quality Control functions like 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 send method of analysis and follow up of them.
● Laboratory setup as per user and safety requirements
● 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, Maintain the approved supplier list. 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. Intermediate and inprocess, stability analysis
● Raw material analysis of active, Inactive material. Volumetric solution preparation and standardization.
● Water analysis of raw, WFI, PW, SAP record results, COA and review
● Decontamination, Cleaning Validation of API.
● Calibration of Analytical Balance, FTIR, UV, HPLC, Dissolution, Autotitrator, Refractive index, polarimeter, PH- meter, MP, Bulk density LOD Oven. Analytical method validation.
● 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.
● Attaint Various Training program, data integrity
● Attaint to regulatory audits.
Sun pharmaceutical Ltd. Halol
Quality Control Officer- Quality Control, Mar.2004 to Sep. 2006
● Sampling and Labelling of Domestic, Expo. Active, Inactive, ANDA material
● Raw material analysis of Domestic, Expo and ANDA active, Inactive material. Water analysis of raw water, WFI, PW. 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 inprocess analysis. LIMS record results, COA
● 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.
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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, Power point,Internet surfing and literature collection.
● Diploma in Computer applications
Other Information:
● NCC ‘C’ Certificate holder
● Scout, Best fires award.
PERSONAL PROFILE:
● Name : Mr. Kiran Prakashchand Bhandari
● Date of Birth : MAR -1979
● Sex : Male
● Marital Status : Married
● Nationality/Race : Indian/Asian
● Language Fluency : English, Hindi, Marathi and Marwari
● Leisure Activities : Reading, Internet surfing and Learning something new, Music
● Personal Strength : A good listener, Positive Attitude, Hardworking, Logical thinking.
● Permanent Address : A2/507, Tirupati campus Phase III, Adarsha colony, road no.2, Tingarenagar,Visharantwadi,Pune-411015,Maharashtra DECLARATION:
I positively assured that all the information mentioned above are true and correct to the best of my knowledge.
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