Sejalkumari Patel
Regulatory Documentation Specialist
Experience
Sep 2022 - Dec 2024
2 years 4 monthsAhmedabad, India
Regulatory Documentation Specialist
VRS Healthcare
- Prepared and reviewed finished product and raw material specifications as per USP, BP, EP, IP, and in-house standards.
- Developed and reviewed SOPs, analytical method validation and transfer, and comparative dissolution studies.
- Reviewed stability, DMF, and cleaning validation documents; resolved regulatory queries.
- Supported QA and RA departments to ensure compliance with GMP and site audit readiness.
Jan 2019 - Sep 2022
3 years 9 monthsSurat, India
Sr. Executive – Analytical Development Lab (ADL)
Globela Pharma Pvt. Ltd.
- Supervised QC personnel for analysis, documentation, and compliance under GLP regulations.
- Conducted analytical method validation, transfer, and comparative dissolution; initiated and reviewed change controls.
- Reviewed analytical reports, calibration, and qualification documentation for all analytical instruments.
- Prepared OOS, OOT, and lab incident reports; ensured timely closure and CAPA implementation.
- Trained team members on SOPs, STPs, and GLP procedures; handled document uploads in SAP.
Mar 2018 - Jan 2019
11 monthsSurat, India
QC Analyst
CTX Lifesciences Pvt. Ltd.
- Prepared and reviewed specifications, methods of analysis, and protocols for raw and finished products.
- Performed calibration of laboratory instruments and ensured lab compliance during audits.
Nov 2014 - Apr 2017
2 years 6 monthsSurat, India
QC Executive
Globela Pharma Pvt. Ltd.
- Conducted testing of raw materials, finished products, and stability samples.
- Executed calibration of equipment and preparation of laboratory reagents.
- Prepared finished product and raw material specifications in line with pharmacopoeia standards.
Apr 2014 - Nov 2014
8 monthsLimla, India
QC Chemist
Hajoori & Sons
- Performed raw material and packing material testing and modified relevant test procedures.
Sep 2013 - Apr 2014
8 monthsIndia
Senior Laboratory Technician
Nakoda Diagnostic & Research Center
- Operated analytical instruments such as cell counter, MINI VIDAS, and auto-analyzers for biochemistry and hematology tests.
Apr 2012 - Aug 2013
1 year 5 monthsSurat, India
Chemist
Span Diagnostics Ltd.
- Conducted analysis and sampling of raw and packing materials.
- Ensured compliance with ISO-QMS and WHO-GMP requirements.
Aug 2011 - Dec 2013
2 years 5 monthsSurat, India
Senior Laboratory Technician
Samarth Pathology Laboratory
- Conducted hematology, biochemistry, and microbiology analysis using automated analyzers.
Summary
Self-motivated and detail-oriented Quality Control and Regulatory Documentation Specialist with over 10 years of progressive experience in the pharmaceutical industry. Skilled in GMP documentation, analytical method validation, regulatory submissions, and compliance with global pharmacopoeias (USP, BP, Ph. Eur, IP). Demonstrated expertise in leading QC teams, managing audits, and ensuring data integrity under 21 CFR Part 11 and GLP guidelines. Seeking a senior-level position in Quality Control, Documentation, and Regulatory Compliance with a reputed pharmaceutical organization.
Skills
- Analytical Method Validation (Amv)
- Regulatory Submissions
- Gmp Documentation
- 21 Cfr Part 11
- Hplc
- Qc/qa Documentation
- Pharmacopoeia (Usp, Bp, Ph. Eur, Ip)
- Calibration And Troubleshooting
- Sop And Protocol Writing
- Glp And Audit Readiness
- Dmf Review
- Lab Incident Investigation
- Sap Documentation
- Regulatory Compliance
Languages
Gujarati
NativeHindi
AdvancedEnglish
IntermediateGerman
ElementaryEducation
Oct 2024 - May 2026
Berlin School of Business and Innovation (BSBI)
M.Sc. · International Healthcare Management · Berlin, Germany
Jun 2008 - Jul 2011
Sikkim Manipal Institute of Technology (SMU)
B.Sc. · Biotechnology · India
Certifications & licenses
Being Well Microcredential
Certificate Of Introduction To GMP
Communication Skills– Career Launchpad
General Awareness On First Aid
Introduction To GMP Annex 1
The Human Connection: Healthy Interpersonal & Professional Relationships
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