Gautamkumar Bhadanee
Pune
Summary
- A self-initiated and dedicated life science quality specialist with a record of achievements in multidisciplinary projects.
- 10 plus years of progressive experience in Quality Assurance department of Biopharmaceuticals industries.
- Actively involved and contributed to many regulatory inspections including USFDA, EMA, PMDA, TGA, ANVISA, health Canada, etc. Played major role of front-line contributor in USFDA and EMA audit at Lupin Biotech from backroom management to explainer as SME.
- Excellent communication skills including fluent in writing, speaking, listening and reading. Certified by IELTS.
- Excellent decision-making skills with thorough understanding on quality system. Problem solving, Proactive and visualization skills, mentor and analytical thinking ability.
- To be associated with a dynamic organization that provides work-driven environment where I can benefit the organization to the best of my ability and at the same time enhance my technical and professional skills.
Overview
11
11
years of professional experience
1
1
Certification
Work History
Manager - Quality Assurance
Lupin Limited (Biotech Division)
Pune
02.2015 - Current
- At Lupin; Promoted to Manager - QA (April, 2022); Promoted to Senior Executive - QA (July, 2019); Promoted to Executive - QA (July, 2017). Joined as Officer QA (Feb, 2015)
- Overall responsibility of QA supervision including Pharmaceutical Quality system review, inspection readiness for internal and external audits, compliance monitoring and communication with higher management.
- Responsibility for Quality Control activity, Quality Management System documents, oversight for product testing and review, associated activities like calibration data, preventive maintenance, review and approval of LIMS related activity, include review of batch documentation and investigations.
- Core responsibility of handling (Review/ Approval) of QMS documents including investigations through digital QMS (Caliber and TrackWise) system. Managing Deviation, Laboratory Incidents, Out of specification (OOS), Out of trend (OOT), cause analysis, Investigations, etc.
- Periodic review, monitor, support site and global quality policies and procedures to ensure GMP compliance. Identification of quality system gaps work towards fixing them through preparation of technical reports and trends for QMS events like Deviations, OOSs, Laboratory indents, Change controls, etc.
- Certified GMP trainer, participate and conduct c-GMP Trainings to improve the awareness and controls. Always support and motivate learners to participate in overall training process and reduce the errors. Currently working on Human errors and exploring Error Risk Reduction concept (ERR).
- Preparation / revision of Quality system SOPs according to latest GMP regulation and industry practice. Routinely reviewing and following ICH, FDA 21 CFR, EU guidelines, PDA technical reports and FDA 483 / warning letters.
- Excellent trouble shooting skills with on time decision on events / documents related to QC sections (Analytical, Bioassay, Microbiology and input materials). Good understanding on Microbiological techniques like BET, Bioburden and Sterility assurance.
- Handling data review of stability and Batch Release including Analytical raw data review like electronic records and paper data related to In-process, critical intermediates, DS and DP.
- Review and approval of GMP Documents (SOP, EOP, STP, Specification, Method Qualification / transfer, Method Validation protocols and reports).
- Perform Gemba walk to check compliance in the Quality control to ensure any quality risks identified are proactively mitigated.
- Site coordinator for internal quality audits / self-inspection; work towards continuous improvement in system and productivity by close coordination with CFT members.
- Periodic meeting with cross functional team for feedbacks and improvement plans; conducting meetings higher management for related support and resources.
- Coordination with outside customers or business partners like Contract Manufacturing organizations (CMO) and Contract testing labs (CTL) at different parts of the world (Europe, Japan and others).
Executive - Quality Assurance
Intas Biopharmaceuticals Pvt. Ltd.
Ahmedabad
06.2012 - 02.2015
- Excellent working knowledge of industry trends and improvements in processes.
- Review of data, i.e., raw data, metadata (HPLC, GC, UV, IR, KF Auto titrator)
- Onsite Investigation of Laboratory QMS, OOS, OOT, Incident/event, OOC.
- Batch release data review for intermediate, DS and DP with analyst qualification and non-routine study data.
- Management of charging and withdrawal of stability samples including on time completion of analysis for RA submission.
- Maintenance of control sample (Tracking, storage and issuance)
- Ensures the activities in accordance with GLP and ALCOA to assures the data reliability and compliances (Data integrity).
Senior Research Fellow
Sardar Vallabhbhai National Institute tech (SVNIT)
Surat
02.2012 - 06.2012
- Developed Biosensor based on porous silicon for detection of biological deceases.
- Applied knowledge of gold coated nanoparticles for biosensor development.
- Employed expert knowledge to design and deliver appropriate research approaches, adapting existing methods and utilizing new ones.
- Tested hypotheses, analyzed data and contributed ideas for new research projects.
Officer - Production
SPAN Diagnostics Ltd
Surat
11.2011 - 02.2012
- Developed gold coated nanoparticles for manufacturing of diagnostic kits.
- handled different kind of diagnostic equipment including PCR, microscope, diagnostic kit assembling machine, LAFU, etc.
- Learned many microbiological tests being used for histo-pathology laboratory.
Education
Master of Science - Biotechnology
CGBIBT affiliated to VNSGU
Gujarat, India2011
Bachelor of Science - Biotechnology
CGBIBT Affiliated to VNSGU
Gujarat, India2009
Higher Secondary School Certificate - Science
Priyadarshani Vidyalaya, Surat
Gujarat, India2006
Skills
- Proactive, Quick learner with change adaptability
- Thorough understanding of biologic's (process/products), pharmaceutical quality systems and regulatory requirements related to the manufacturing, testing, release and stability studies
- Excellent interpersonal, verbal and written communication skills Results oriented, with the ability to manage multiple priorities
- Able to think critically and problem-solving skills Self-starter and self-motivated; organized with good attention to detail and decision-making skills
- Flexible to work in a fast-paced environment and able to adjust workloads based on business priorities
- Holding a team lead role since last 4 years and mentoring 10 members by ensuring involvement and contribution of each teammate for their personal and organizational growth
Accomplishments
- Best SME Award during explanation for USFDA and Health Canada Audit – Dec’ 2022
- Awarded as “Performance Significant Above Plan” (PSAP) for continuous two years (2020 & 2021)
- Two times Awarded as a “Best Employee of the Month” in 2016 and 2018 at Lupin Limited (Biotech division).
- Awarded as “Value Rangers” for Cofepris audit handling and success at Lupin (Dec-2018).
- Awarded as “Value Rangers” for PMDA and EMEA audit handling and success at Lupin (May – 2019).
- Actively handled more than 15 regulatory audits and got successful outcomes always.
Affiliations
- Promoted to Manager - QA (April, 2022)
- Leading a team of 8 members and delivering the best outcomes in the department.
- Core team member of "Digitalization in Quality system".
Certification
- Certified GMP trainer for Quality system including QC and QA functions
- IELTS Certified (International English Language Testing System).
- Two times employee of the Month winner.
Languages
English
Proficient
C2
Hindi
Advanced
C1
Gujarati
Bilingual or Proficient (C2)
Timeline
Manager - Quality Assurance
Lupin Limited (Biotech Division)
02.2015 - Current
Executive - Quality Assurance
Intas Biopharmaceuticals Pvt. Ltd.
06.2012 - 02.2015
Senior Research Fellow
Sardar Vallabhbhai National Institute tech (SVNIT)
02.2012 - 06.2012
Officer - Production
SPAN Diagnostics Ltd
11.2011 - 02.2012
Master of Science - Biotechnology
CGBIBT affiliated to VNSGU
Bachelor of Science - Biotechnology
CGBIBT Affiliated to VNSGU
Higher Secondary School Certificate - Science
Priyadarshani Vidyalaya, Surat
- Certified GMP trainer for Quality system including QC and QA functions
- IELTS Certified (International English Language Testing System).
- Two times employee of the Month winner.
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