BHAVIK PATEL
Ahmedabad
Summary
Lead Investigator with significant experience at Intas Pharma, specializing in quality management and compliance. Demonstrated success in root cause analysis and audit management, collaborating with consultants to improve regulatory adherence. Expertise in data analysis and training coordination, fostering continuous improvement in laboratory operations and compliance strategies.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Lead Investigator
Intas Pharma
Ahmedabad
04.2021 - Current
- Led QMS investigation team of 11 members for OOS, OOT, incidents, deviations, and CAPA.
- Conducted thorough investigations to identify causes of OOS and OOT events.
- Collaborated on laboratory compliance with audit findings from USFDA, TGA, ANVISA, and European regulators.
- Executed interviews and investigations to uncover potential evidence sources.
- Engaged consultants for compliance strategies addressing FDA observations from Lachman, QxP, Quality Culture, Quantic, and Vector.
- Gained extensive experience managing various regulatory audits.
- Gathered and analyzed data from multiple sources to determine investigative strategies.
- Carried out the various investigations along with the third-party consultants, i.e. Lachman, QxP, Quantic, and Quality Culture communicate the activities and strategies.
Lead Investigator
Sun Pharma
07.2016 - 03.2021
- Led investigations of out-of-specification, out-of-trend, and laboratory events within QMS team.
- Managed change control, CAPA, and deviation processes to ensure compliance.
- Served as training coordinator for department, facilitating ongoing professional development.
- Prepared standard operating procedures using EDMS software for improved accessibility.
- Operated laboratory instruments, including HPLC, FTIR, UV, and Karl Fischer.
- Participated in installation of new laboratory instruments, including URS and risk assessments.
- Ensured audit compliance through thorough documentation and process adherence.
Analyst
Torrent Pharma
08.2012 - 06.2016
- Involved in chemical analysis of finished product and raw material
- Involved in XRD analysis
Education
Pharmacy -
Bapuji Pharmacy College
12.2011
HSC -
Shri H L Patel Sarasvati Vidyalaya
01.2007
SSC -
Shri K B Patel Highschool
01.2005
Skills
- Quality management and compliance
- Data analysis and interpretation
- Laboratory software expertise
- Standard operating procedures
- Training coordination and delivery
- Instrument qualification and validation
- Root cause analysis
- Audit management
- Consultant collaboration
- Root cause analysis and corrective actions
- Audit management and oversight
- Consultant collaboration and communication
- Root cause analysis and corrective actions
- Audit management and oversight
- Consultant collaboration and communication
- Root cause analysis and corrective actions
- Audit management and oversight
- Consultant collaboration and communication
Projects
Quality circle, Reduced the laboratory incidents by using quality circle concept
Achievementsawards
- PAR Excellence Award winner in quality circle at national level
- Sunstar Award
Accomplishments
- Role model in quality control
- Gold winner in the Quality Circle Program
- Sun Star Award
Certification
- Certified investigator
- ISO-certified auditor
- Certified investigator by CBE consultant
Languages
English
First Language
Hindi
Beginner (A1)
A1
Gujarati
Beginner
A1
Timeline
Lead Investigator
Intas Pharma
04.2021 - Current
Lead Investigator
Sun Pharma
07.2016 - 03.2021
Analyst
Torrent Pharma
08.2012 - 06.2016
Pharmacy -
Bapuji Pharmacy College
HSC -
Shri H L Patel Sarasvati Vidyalaya
SSC -
Shri K B Patel Highschool
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