Summary
Overview
Work History
Education
Skills
Accomplishments
Interests
Timeline
DEEPESH UMAJI GHARAT

DEEPESH UMAJI GHARAT

Quality Assurance Manager
Palghar

Summary

PROFESSIONAL SNAPSHOT A competent and seasoned professional with over 12 + years of experience in the field of Quality Control Department and 3 + years of experience on Quality Assurance Department. Presently associated with Piramal Pharma Limited as Manager Corporate Quality Assurance Strong communication, interpersonal, analytical, problem solving and relationship building skills. Believing in Teamwork and team capabilities to achieve stretched goals for an organizational benefits.

Overview

20
20
years of professional experience
1
1
year of post-secondary education
3
3
Languages

Work History

QUALITY ASSURANCE MANAGER

LUPIN LIMITED
MUMBAI
05.2023 - Current
  • Participation in all HR initiatives such suggestions schemes, Cost saving projects, Error risk reduction, buddy projects, leaded location for inter location cricket tournament held yearly
  • Undergone Accenture green belt training and successfully completed 2 green belt project’s that are “Increasing HPLC utilization for QC section and Cost savings in QC Consumables”
  • Validated Savings of Rs.53 lacs were outcome of cost savings project and 4 HPLC procurement was deferred outcome of HPLC utilization of project
  • Accomplished best green belt project by Managing director of LUPIN
  • Mr
  • Nilesh Gupta
  • Project was presented at HO Mumbai
  • Completed Black belt up gradation BMGI training at LLC, Lonavala in year 2017
  • Imparted DMAIC training for 48 hours at Lupin Mandideep and Vizag locations for various projects against lean six sigma concept
  • Certified by management in 2009 for successful demo HPLC and GC analysis of finished product to USFDA auditor and explaining the procedure of the same with product and chromatography basis
  • Certified by management in 2011 for successfully completion of analysis of 510 batches for related substance test to be analyzed by HPLC for a product in 5 successive days which were requirement for a product recall
  • Certified as internal auditor through 2 days training programme by cGMP auditors Ankeleshwar division, Handling audit observations and compliance for all sites including India, US and UK areas
  • Handling of presentations for management reviews across sites
  • Corporate guidelines revision in line with current FDA guidance /ICH guidelines
  • Technical support related to QA and QC roles for all sites during USFDA audit remotely
  • Deputations at sites prior to announced USFDA audits to review the site readiness and provide guidance with respect to compliance
  • Performing CQA audits for all sites for formaulations,API and intermediates for self-manufacturing and subsidiaries.
  • Implemented new quality assurance and customer service standards.
  • Recorded, analyzed, and distributed statistical information.
  • Inspected products and worker progress throughout production.
  • Reported production malfunctions to managers and production supervisors.
  • Assured consistent quality of production by implementing and enforcing automated practice systems.
  • Monitored staff organization and suggested improvements to daily functionality.
  • Collaborated with cross-functional teams to develop and implement process and system improvements.
  • Conducted risk assessments to identify and mitigate potential quality issues.
  • Investigated customer complaints and performed corrective actions to resolve quality issues.
  • Created and maintained quality management systems to align with industry standards.
  • Performed root cause analysis to identify and resolve quality issues and defects.
  • Evaluated interactions between associates and customers to assess personnel performance.
  • Conducted process and system audits to identify areas of improvement and enforce compliance with industry standards.
  • Developed and implemented comprehensive quality assurance plans to monitor product quality and adherence to regulatory standards.
  • Assessed product quality by monitoring quality assurance metrics, reports and dashboards.

Manager

PIRAMAL PHARMA LIMITED
Mumbai
12.2022 - 04.2023
  • Resolved staff member conflicts, actively listening to concerns and finding appropriate middle ground.
  • Accomplished multiple tasks within established timeframes.
  • Cross-trained existing employees to maximize team agility and performance.
  • Maximized performance by monitoring daily activities and mentoring team members.

MANAGER QUALITY ASSURANCE DEPT

LUPIN LIMITED
TARAPUR
03.2019 - 11.2022
  • Handling QA Investigation section, which includes overall investigations related to Deviations, Out of specifications, Out of trends, Extraneous matters, Market Complaints, Out of Calibrations and Laboratory incidences with cross functional team members to gather information and reach to root causes of the events and concluding for batch decision
  • Handling Change controls, CAPA, Deviation as per guidelines through QAMS software with proper tracking and timely closures
  • I am involved as a site QA lead function for handling these investigations through cross functional team members and conclude with proper root causes and initiating and tracked through CAPA to avoid recurrences
  • All activities are handled through e-Caliber QAMS software
  • Handling analytical review section where all types of analytical documents from Quality Control are reviewed
  • Documents which are handled are analytical method transfers, Analytical method validations, Life cycle management of analytical methods which includes all analytical techniques as HPLC,GC,ICPMS,GCMS,XRD,FTIR,UV etc
  • Ensuring on time trending of OOS/OOT/Deviation and Market complaints
  • Handling batch release team responsible for releasing batch as per laid down procedure and as per weekly planning’s
  • This activity includes overall review of batch production records and analytical data sheet and related events
  • Maintaining compliance against Pharmacopoeia updates for USP/Ph.Eur/JP/IP/BP
  • Handling routine work including vendor Qualification for solvents, Key starting raw materials/general raw materials etc
  • With team of 2 persons
  • Handling Routine API sampling with team of 8 members with three tier sampling practice
  • Handling Stability section, which includes stability packing, incubation, pullouts and Approval of reports with stability summaries
  • Maintaining document cell with team members, handling all documents archival, retrieval, storage and destruction of overall site
  • Handling specification preparation 6 members team for preparing all types of specification at site including RM/PM/In process/Intermediates/API and stability
  • Handling all marketing queries, requirements and responding in stipulated timelines to connect with new business opportunities
  • Handling complete internal activities to support production maintain complaince all time
  • Handling self-inspection section to comply with guidelines requirement and drives with team of auditors allocated for scheduled activity
  • Handling Annual product review (APQR) for all API’s as per Annual planner staggered through the year
  • In APQR, overall manufacturing process and analytical data is collated, trended and evaluated to note the findings and if required proper controls and actions are initiated
  • Handling all issues related to QA department to resolve with maintaining complaince and without hampering production activities
  • Conducting interviews for various positions in Quality Assurance through HR team.

Manager

LUPIN LIMITED
Tarapur
05.2007 - 11.2022

MANAGER QUALITY CONTROL

LUPIN LIMITED
05.2007 - 03.2019
  • Handling Quality control lab with 16 officers/executives reportees
  • Core function of working includes installations of instruments in QC laboratory, Calibration of instruments, Qualification of instruments, Working standard qualifications, Analytical method transfers, Analytical method developments, Analytical method equivalency, Preventive maintenance of instruments, Cleaning method validations, Regulatory query responses
  • Ensuring Installation of instruments through proper IQOQPQ documentation as per USP requirements
  • Ensuring periodic Nitrogen gas analysis produced at utility block which is used for various process activities
  • Handling customer and regulatory audits individually and complying the audit observations
  • Maintaining QC lab with documentation as per USFDA requirements
  • Support to production department with all types of analysis required during inprocess, Intermediate checks and support during API testing and releasing during scheduled dispatches to Lupin other locations and Vendors
  • Attending telecoms with other locations for discussing method transfers issues and accordingly resolving with team
  • Support to all Lupin locations for providing working standards and analyzing XRD test samples
  • Procurements and maintenance of all Quality control consumables, Reagents, Solvents etc
  • To ensure smooth functioning of all QC labs
  • Maintaining monthly budget for Quality control dept
  • To know the trend of expenditures and if required to control
  • Authorized for committee commercial negotiation done during procurements of high value items
  • Conducting training for QC analyst for all analytical instruments techniques
  • Performed trending of OOC/Lab incident and extraneous peak
  • Proper utilization of CAPEX budget with planning procurements according to need of laboratory to cater workload and maintain compliance
  • Preparation and implementation of Standard operation procedures to ensure compliance with respect to harmonized working practices in laboratory
  • Utilizing SAP modules for maintaining of types of schedulers for calibration, preventive maintenance, working standard management
  • HPLC /GC columns management done through SAP
  • Ensuring proper training and qualifications to new joining analyst with various techniques in QC instruments before starting active work
  • Ensuring complete safety is followed during working in laboratory for all laboratory staff
  • Ensuring trending data for all products maintained in MINITAB software for proper understanding of analysis data
  • Ensuring proper and timely investigations for OOS, OOT, OOC, Deviations observed in Quality control laboratory and target to achieve all root causes of the events and provide CAPA to avoid the recurrence of the events with actions that are documented and implemented
  • Completing quality risk assessment as per requirement of any activities to fulfill the compliance needs
  • Completing cross functional team meetings on scheduled manner to prioritize the work as per business requirements to achieve business goals
  • Implementing new projects like error reductions, incidence reduction driven through corporate operation excellence dept
  • With monthly calls for projects status and actions
  • Driving cultural change for maintaining a cost effective QC lab with involving team members with valuable suggestions and implementing them resulting in organizational financial benefits
  • Troubleshooting all instruments installed in QC lab in ODD hours to mitigate the challenge and resolve breakdowns online for timely delivery of commitments
  • Maintaining contracts for all instruments in form of AMC/CMC on yearly basis to avoid frequent breakdowns
  • Closing complete commercial bills, invoices in line with accounts department requirements
  • Ensuring GMP agreements with all contract vendors and testing labs
  • Completing vendor development activities with vendor audits and documentation
  • Ensuring all software’s are validated before use and complying 21 CFR requirements and there is no data integrity risk involved
  • Ensuring temperature mappings for all areas including QC labs, stability chambers, Refrigerators, Cold chambers, BOD incubators is performed timely and rationally
  • Maintained all external calibrators and get calibrations done through external NABL certified calibration labs
  • Maintaining properly documented procedures for Change controls through QAMS and timely closures of tasks generated during the change procedures
  • Ensuring all administrative controls maintained in Quality control laboratory
  • Drive done for laboratory incidence reduction with brainstorming sessions in all QC labs
  • Completing all task allocated by senior management to achieve the business goals by percolating the desired information to the team through timely meetings
  • Conducting interviews for various positions in Quality control through HR team
  • Mentoring QC team members in various allocated projects in preparing presentations and execution of the projects
  • Recently completed elemental risk analysis for all products with respect to USP 232 /23- chapter implementation
  • Handled analytical instruments as (Instruments Hand’s On)
  • High Performance Liquid Chromatography [Shimadzu, Waters, Dionex, Agilent]
  • Gas Chromatography [Shimadzu/Agilent and Perkin Elmer]
  • FTIR Spectrophotometer [Shimadzu]
  • U.V
  • Spectrophotometer [Shimadzu]
  • Thin Layer chromatography
  • Polarimeter [Rudolf/Autopol]
  • Refractometer [Rudolf]
  • Autotitrator/ Coulometer and Karl Fischer Instruments [Metler Toledo and Metrohm]
  • X-Ray Diffractometer [Rayons (Panalytical)]
  • Particle size analyzer [Malvern]
  • Thermogravimetric analyzer [Perkin Elmer]
  • Density meter [Anton Paar]
  • Spectrofluorometer [Shimadzu]
  • Melting Point /Moisture Balance: Metler Toledo
  • Density meter [Anton Paar]
  • Ion Chromatography/ VOLTAMETER [Metrohm]
  • I.R
  • And Halogen moisture balance [Shimadzu ,Metler Toledo and Ohaus]
  • Mass spectroscopy with LC [Waters]
  • ICP-MS
  • GC-MS
  • ALL THESE INSTRUMENTS ARE INDIVIDUALLY HANDLED AND ARE COMPLYING THE REQUIREMENTS OF 21CFR PART 11.HAVING TOTAL HARDWARE AND TROUBLESHOOTING KNOWLEDGE OF ALL MENTIONED INSTRUMENTS
  • WHILE WORKING WITH FORMULATION PLANT
  • At Officer grade Performed raw material ,in process ,Finished Product analysis for various antimalarial, antipyretic and contraceptic analysis for various dosage forms like Tablets , Capsules , Pessaries ,Suppositories , Injections and Oral suspension for various tests using different instruments like Disintegration test apparatus for Tablets ,Capsules ,Pessaries and Suppositories
  • Friability Test Apparatus
  • Bulk Density Apparatus
  • Dissolution Test apparatus for Tablets ,Capsules ,Pessaries and Suppositories
  • AUDITS EXPERIENCE
  • USFDA audit faced in 2009 ,2012 ,2015,2018,2019
  • MHRA audit faced in 2010
  • WHO audit faced in 2008 ,2011,2014 and 2017
  • ANVISA audit faced in 2012 and 2017
  • LACHMAN CONSULTANCY audits faced in 2009,2012 ,2013,2015,2017
  • COFEPRIS audit faced in 2014
  • PMDA Japan audit faced in 2018

QC Officer

BLISS GVS PHARMA LTD
Palghar
01.2006 - 05.2007

QC Officer

McCoy Pharma PVT. LTD
Boisar
11.2004 - 12.2005

Education

Bachelor of Science - Chemistry

University of Mumbai
GPA: .75 %

MSC - Chemistry

Vinayaka Mission University
06.2013 - 04.2014
GPA: 67 %

Certificate course in Information Technology, Office Automation and computer hardware and networking - undefined

Skills

Quality control tests

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Accomplishments

  • PARAXEL CONSULTACY AUDIT faced in 2018
  • Vendors, Consultancy audits and QP audits faced almost every month
  • National Accreditation Board for Testing and calibration Laboratories
  • STATE FDA ACTIVITIES
  • Approved as competent staff in Chemical and Instrumentations through Maharashtra food and drugs administration
  • Maintained liaising details for site QA for all products manufactured
  • Maintained SUGAM portal details and handled complete compliance of application for written confirmation, WHO-GMP certification,COPP’s CORPORATE SOCIAL RESPONSIBILTIES
  • Involved in CSR activity from year 2016, wherein started a diploma course through LUPIN CSR team at Dandekar College Palghar
  • This diploma course comprises of contents beneficial and part of Quality control laboratory
  • Main agenda of the course is to bridge the gap between academic curricula and actual industry requirements and for job orientation of Palghar district students
  • Also, course design for contractual employees for training period after completion of BSc
  • PRODUCTS AND DOSAGE FORMS WORKED WITH
  • Worked with dosage forms as suppositories, pessaries, tablets, capsules, dry syrup and injections in formulation unit
  • Worked with products such as: Rifampicin, Pyrazinamide, Lovastatin, Rifaximin, Levetiracetam, Rifabutin, Ethambutol Hydrochloride, Ramipril, Simvastatin, Sertraline HCl, Losartan Potassium, Ziprasidone HCl, Sevelamer Carbonate, Sevelamer HCl, Colesevelam HCl, Memantine HCl, Celecoxib, Tenofovir Diisoproxil Phosphate, Telmisartan, Eszopiclone, Abacavir HCL, Abacavir Sulfate, Ranolazine, L-Methyl tetrahydro folate.etc
  • FUTURE PERSONALISED GOALS
  • To work with organization which is genuine in medicine making and which knows the importance of patient safety
  • Lead Quality department to support organizations built up a better Quality culture which can benefit to business
  • Job satisfaction which includes self and organization benefit through planned and structured manner of working
  • Achieve business goals working with organization desperate of growth in pharma industry
  • Develop a work culture to sustain in global world of compliance requirement in pharma industry.

Interests

Cricket ,Driving

Timeline

QUALITY ASSURANCE MANAGER - LUPIN LIMITED
05.2023 - Current
Manager - PIRAMAL PHARMA LIMITED
12.2022 - 04.2023
MANAGER QUALITY ASSURANCE DEPT - LUPIN LIMITED
03.2019 - 11.2022
Vinayaka Mission University - MSC, Chemistry
06.2013 - 04.2014
Manager - LUPIN LIMITED
05.2007 - 11.2022
MANAGER QUALITY CONTROL - LUPIN LIMITED
05.2007 - 03.2019
QC Officer - BLISS GVS PHARMA LTD
01.2006 - 05.2007
QC Officer - McCoy Pharma PVT. LTD
11.2004 - 12.2005
University of Mumbai - Bachelor of Science, Chemistry
- Certificate course in Information Technology, Office Automation and computer hardware and networking,

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DEEPESH UMAJI GHARATQuality Assurance Manager