Pinkal Patel
Quality Manager And Analytical Scientist
Parahill West
Summary
Quality Manager and Analytical Scientist with over 12 years of experience in pharmaceutical, food, and clinical research. Proficient in Quality Management Systems, regulatory compliance, and analytical testing. Demonstrated success in leading teams, conducting audits, and managing CAPA processes. Experienced in regulatory submissions to TGA, EMA, MHRA, Health Canada, and USFDA.
Overview
14
14
years of professional experience
Work History
Quality Auusrance Manager and Chemist
BIHD, Food Manufacturing Company
01.2023 - Current
- Developed and aligned QMS with ISO, HACCP, GMP, FSANZ, BRCGS, SQF standards.
- Conducted comprehensive audits and compliance checks for internal and supplier operations.
- Managed product development including formulation and sensory evaluation.
- Oversaw allergen testing, nutritional analysis, and shelf-life validation processes.
- Leading investigations into deviations, addressing customer complaints with CAPA strategies.
- Trained teams on GMP, HACCP, SOPs, ensuring food safety and traceability standards.
- Maintained HACCP plans, process controls, and batch records systematically.
- Managed raw material monitoring, microbial testing, and final product release.
Quality Assurance Manager & Regulatory Affairs
Accord Healthcare Limited
11.2014 - 03.2022
- Coordinated artwork development and ensured compliance with EU labeling guidelines through cross-functional collaboration.
- Executed change control procedures while maintaining artwork databases and real-time approval trackers.
- Provided regulatory guidance for product design and submission of marketing authorization applications.
- Analyzed samples from F&D department, interpreted data, and prepared specifications for method development.
- Employed advanced analytical techniques including GC, HPLC, UV, and FTIR for research submissions.
- Verified APIs, prepared methods and certificates, and reviewed documents for regulatory approval.
- Supported QA and Pharmacovigilance functions, addressing QP queries regarding variation approvals.
R&D Specialist
Amneal Pharmaceutical Limited
11.2013 - 10.2014
- Developed innovative analytical techniques for drug products, conducting dissolution and stability studies.
- Collaborated with cross-functional teams to validate methods and equipment for new analytical processes.
- Applied IVIVC knowledge within GLP compliance, leveraging QbD principles for enhanced reliability.
- Performed calibration and troubleshooting of routine analytical instruments to maintain operational efficiency.
- Led development and validation of cleaning, assay, CU, BU methods for raw materials and API verification.
Senior Research Associate
Cliantha Research Limited
01.2012 - 11.2013
- Conducted bio-analytical methods including LLE, SPE, and PPT for BA/BE studies on plasma, serum, blood, and urine samples.
- Operated and maintained analytical instruments such as LC/MS/MS, HPLC, and ICP for diverse assays.
- Ensured compliance with GCLP, GLP, GDP, WHO, and FDA guidelines through meticulous documentation practices.
- Maintained calibration records and performed regular maintenance on laboratory instruments, including pH meters and centrifuges.
- Documented maintenance of Reference Standards and managed Clinic Sample handling procedures.
- Prepared Certificates of Analysis (COA) for new drugs while adhering to SOP requirements.
- Oversaw laboratory delegation and ensured proper functioning of all equipment as per established protocols.
- Executed wet analysis processing to uphold high standards of project compliance.
Education
MBA - Project Management
Sikkim Maniple University
India01.2014
MS - Pharmacology, Life Science
Hertfordshire University
United Kingdom01.2011
Bachelor of Pharmacy - Pharmacy
Rajiv Gandhi University of Health Science
India 04.2001 -
Skills
QMS and compliance: ISO, GMP, HACCP, FSANZ, BRCGS, SQF
Regulatory affairs: EU, TGA, MHRA, Health Canada, and USFDA submissions, labeling, and dossier management
Analytical techniques: HPLC, GC, UV, FTIR, KF, dissolution, stability testing, LC-MS, ICP-MS, particle size analysis
Laboratory and R&D: method development, validation, QA review, documentation, clinical study, BA/BE
Risk and audit: supplier/internal audits, deviations, CAPA implementation
Team leadership: training staff on GMP, HACCP, SOPs, traceability, GCP, and GDP
ACHIVMENTS & CERTIFICATES
- Australian Food safety society: Food safety supervisor and Food Manager
- Regulatory Compliance and Quality Assurance: MHRA, EMA, USFDA, Health Canada and TGA
- Indian Pharmacy Council: Register Pharmacist
- National Pharmacy Association, UK: Register Pharmacologist
- Industrial Licenses: Particle Size Analyst, HPLC Specialist, LC MS MS specialist.
- Technical: Microsoft Office and IT skills.
- Awards: Employee of the Year: Accord Healthcare Limited & Brexit/FMD Project Achiever.
DECLARATION
Hereby I declare that all the above details provided are true to the best of my knowledge and shall provide original testimonials as and when required.
Yours Sincerely,
Pinkal Patel
Timeline
Quality Auusrance Manager and Chemist
BIHD, Food Manufacturing Company
01.2023 - Current
Quality Assurance Manager & Regulatory Affairs
Accord Healthcare Limited
11.2014 - 03.2022
R&D Specialist
Amneal Pharmaceutical Limited
11.2013 - 10.2014
Senior Research Associate
Cliantha Research Limited
01.2012 - 11.2013
Bachelor of Pharmacy - Pharmacy
Rajiv Gandhi University of Health Science
04.2001 -
MS - Pharmacology, Life Science
Hertfordshire University
MBA - Project Management
Sikkim Maniple University