Quality-minded GxP professional with broad experience in research and the pharmaceutical industry,including global roles in Human drug discovery and R&D Quality and Auditing. Experience and expertise in Quality Management Systems, to oversee nonclinical and clinical studies (OECD GLP,GCP - VICH and ICH, USFDA CFR Part 11, GAMP). Customer-close, collaborative mindset with international work-experience, strong communication skills, cultural sensitivity and demonstrated ability to quickly learn and adapt to new projects and environments ensuring compliance and efficiency of processes across the organization. A process improvement champion.
Hi, I’m
Mitul Patel
Quality Assurance
Schofields,Australia
Summary
Overview
15
years of professional experience
7
years of post-secondary education
4
Certifications
Work History
GenesisCare CROSydney, NSW
Research Quality Lead
12.2022 - Current
Job overview
- Compiled and reported quality metrics to analyze trends and drive continuous improvement initiatives within the Quality Management System. This involved identifying key performance indicators, gathering relevant data, and presenting actionable insights for process enhancement.
ELANCOSydney
Consultant R&D Quality
04.2022 - 11.2022
Job overview
- Additional responsibilities to previous role
- Training junior colleagues on GCP and GLP Auditor program
- QMS and General Quality Consultation on regulatory and internal standards requirements
- CSV responsibilities for multiple sites including testing and releasing software for the use of R&D
- Regional Trainer for Veeva QMS Modules
- Hypercare improvements in Veeva Modules based on feedback from global colleagues
- Lead Internal and External Regulatory Inspections
- Lead GCP Auditor Community of Practice
- Vendor Qualifications for applicable services i.e
- CRO Qualifications etc.
D Quality Assuranceat ELANCOSydney
Senior Representative R
08.2019 - 03.2022
Job overview
- Customer close R&D quality expert consultant for compliance and process improvement topics for Clinical
- Development (CD) providing expertise of current regulations – including GCP and GLP- and state of the industry thinking and guidance for internal and external stakeholders
- Acting in close collaboration with the heads of functions, Regional Managers, Compliance Officer/Manager and colleagues in different locations to ensure that processes are designed and performed in compliance with global and national regulatory requirements and company policies, procedures and standards
- Lead auditor conducting internal and study/process-based audits to identify the gaps in the systems and working closely with the business partners to effectively close the identified gaps focusing mainly on making the processes compliant and more efficient
- Ensuring continuous development and refinement of the Global Quality System by participating in SOP authorship and reviews
- Document controlling and training for internal QA documents as and when needed
- Hosting regulatory authority inspections; supporting R&D functions to ensure inspection readiness by provision of e.g
- Pre-inspection audits, conducting audit awareness programs
- Creating and presenting global quality trending reports for Quality Management Review to senior management to serve for further quality improvement and operational excellence
- Closely working business stakeholders to reduce the local backlog for Quality Metrics backlog
- Accredited CSV (CSQ) consultant for computer systems validation
- Have actively participated in roll-out of new tools for Quality Management Systems including TrackWise and Veeva
- User design consultant for various modules in Veeva
- Training and mentoring of less experienced auditors (contract staff) to promote consistency and maintain required standards and increase flexibility within team.
ELANCOSydney
Clinical Study Monitor
01.2018 - 08.2019
Job overview
- Clinical Study Monitoring for VICH GCP studies
- Preparing monitor visit reports and reporting findings to the Sponsors
- Collaborative approach for process improvements by working closely with Quality
- Internal GCP/GLP champion/consultant
Torrent Research Centre, Pharmacokinetics
Scientist-II
01.2009 - 01.2017
Job overview
- Toxicity Studies
- Conducting Pharmacokinetic analysis of lead NCEs for early discovery animal studies and regulated BA-/Phase-I
- Clinical Trials
- Hands on experience working on various software like Phoenix Winnonlin and GraphPad Prism
- Worked as a Study Director for Toxicity studies for GLP submissions
- Initiator and Chair of Quality Excellence Team – A process improvement working group
- Authoring and reviewing SOPs for GLP and GCLP compliance
- Reviewing IND applications, Clinical Study protocols
- Designing and execution of Preclinical and early discovery experiments i.e
- Tissue distribution of NCEs, oral/IV/sc Pharmacokinetic profiling, Biliary Excretion of drugs and its metabolites
- BA/BE Study Protocol reviews as per ICH-GCP
- Strengths/experience helpful for this role:
- Tech savvy - Process Improvements for any processes/QMS Tools
- Proficient in Microsoft Applications like Excel, PowerPoint, Access, Vision, Word, Teams etc
- Computer Systems Validation Skills
- Regulatory Guidelines knowledge around multiple guidelines i.e
- GLP/GCP/VICH GCP/USFDA 21 CFR Part 11/
- GAMP
- Management of QMS records i.e
- Deviations, Change Controls
- Quality Metrics Compilation and reporting to the management
Education
Rajiv Gandhi University of Health Sciences
Master of Pharmacy from Pharmacology
01.2006 - 04.2008
University Overview
Rajiv Gandhi University of Health Sciences
Bachelor of Pharmacy
01.2002 - 04.2006
University Overview
Skills
GCP
undefinedAccomplishments
Accomplishments
- OECD GLP | VICH GCP | ICH GCP | FDA 21 CFR Part 11 | GAMP 5
- PERSONAL STRENGTHS
- Strong intercultural communication skills
- Courageous
- Managing complexity
- Self-reflective
- Driven by results Analytical
- Process Improvements New Systems/Tools Roll-out
- People coach/mentor
- Mitul Patel
Certification
Computer Systems Qualifications (A CSV accreditation program by Elanco)
Timeline
Research Quality Lead
GenesisCare CRO
12.2022 - Current
Consultant R&D Quality
ELANCO
04.2022 - 11.2022
Senior Representative R
D Quality Assuranceat ELANCO
08.2019 - 03.2022
Clinical Study Monitor
ELANCO
01.2018 - 08.2019
Scientist-II
Torrent Research Centre, Pharmacokinetics
01.2009 - 01.2017
Rajiv Gandhi University of Health Sciences
Master of Pharmacy from Pharmacology
01.2006 - 04.2008
Rajiv Gandhi University of Health Sciences
Bachelor of Pharmacy
01.2002 - 04.2006
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