Sejalkumari Patel - Regulatory Documentation Specialist

Q: Where is Sejalkumari based?

Sejalkumari is based in Berlin, Germany .

Q: What languages does Sejalkumari speak?

Sejalkumari speaks the following languages: Gujarati (Native), Hindi (Advanced), English (Intermediate), German (Elementary) .

Q: How many years of experience does Sejalkumari have?

Sejalkumari has at least 12 years of experience. During this time, Sejalkumari has worked in at least 7 different roles and for 7 different companies . The average length of individual experience is 2 years and 7 months . Note that Sejalkumari may not have shared all experience and actually has more experience.

Q: What is Sejalkumari's latest experience?

Sejalkumari's most recent position is Regulatory Documentation Specialist at VRS Healthcare .

Q: What companies has Sejalkumari worked for in recent years?

In recent years, Sejalkumari has worked for VRS Healthcare and Globela Pharma Pvt. Ltd. .

Q: Which industries is Sejalkumari most experienced in?

Sejalkumari is most experienced in industries like Pharmaceutical , Healthcare , and Biotechnology . Sejalkumari also has some experience in Chemical .

Q: Which business areas is Sejalkumari most experienced in?

Sejalkumari is most experienced in business areas like Quality Assurance (QA) and Research and Development (R&D) .

Q: Which industries has Sejalkumari worked in recently?

Sejalkumari has recently worked in industries like Pharmaceutical .

Q: Which business areas has Sejalkumari worked in recently?

Sejalkumari has recently worked in business areas like Quality Assurance (QA) .

Recommended expert

Berlin, Germany

Experience

Sep 2022 - Dec 2024

2 years 4 months

Ahmedabad, 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 months

Surat, 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 months

Surat, 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 months

Surat, 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 months

Limla, India

QC Chemist

Hajoori & Sons

Performed raw material and packing material testing and modified relevant test procedures.

Sep 2013 - Apr 2014

8 months

India

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 months

Surat, 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 months

Surat, India

Senior Laboratory Technician

Samarth Pathology Laboratory

Conducted hematology, biochemistry, and microbiology analysis using automated analyzers.

Industries Experience

See where this freelancer has spent most of their professional time. Longer bars indicate deeper hands-on experience, while shorter ones reflect targeted or project-based work.

Experienced in Pharmaceutical (9 years), Healthcare (2.5 years), Biotechnology (1 year), and Chemical (0.5 years).

Pharmaceutical

Healthcare

Biotechnology

Chemical

Business Areas Experience

The graph below provides a cumulative view of the freelancer's experience across multiple business areas, calculated from completed and active engagements. It highlights the areas where the freelancer has most frequently contributed to planning, execution, and delivery of business outcomes.

Experienced in Quality Assurance (12 years) and Research and Development (2.5 years).

Quality Assurance

Research and Development

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

Native

Hindi

Advanced

English

Intermediate

German

Elementary

Education

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

Profile

Created

January 2026

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Frequently asked questions

Do you have questions? Here you can find further information.

Where is Sejalkumari based?

Sejalkumari is based in Berlin, Germany.

What languages does Sejalkumari speak?

Sejalkumari speaks the following languages: Gujarati (Native), Hindi (Advanced), English (Intermediate), German (Elementary).

How many years of experience does Sejalkumari have?

Sejalkumari has at least 12 years of experience. During this time, Sejalkumari has worked in at least 7 different roles and for 7 different companies. The average length of individual experience is 2 years and 7 months. Note that Sejalkumari may not have shared all experience and actually has more experience.

What roles would Sejalkumari be best suited for?

Based on recent experience, Sejalkumari would be well-suited for roles such as: Regulatory Documentation Specialist, Sr. Executive – Analytical Development Lab (ADL), QC Analyst.

What is Sejalkumari's latest experience?

Sejalkumari's most recent position is Regulatory Documentation Specialist at VRS Healthcare.

What companies has Sejalkumari worked for in recent years?

In recent years, Sejalkumari has worked for VRS Healthcare and Globela Pharma Pvt. Ltd..

Which industries is Sejalkumari most experienced in?

Sejalkumari is most experienced in industries like Pharmaceutical, Healthcare, and Biotechnology. Sejalkumari also has some experience in Chemical.

Which business areas is Sejalkumari most experienced in?

Sejalkumari is most experienced in business areas like Quality Assurance (QA) and Research and Development (R&D).

Which industries has Sejalkumari worked in recently?

Sejalkumari has recently worked in industries like Pharmaceutical.

Which business areas has Sejalkumari worked in recently?

Sejalkumari has recently worked in business areas like Quality Assurance (QA).

What is Sejalkumari's education?

Sejalkumari holds a Master in International Healthcare Management from Berlin School of Business and Innovation (BSBI) and a Bachelor in Biotechnology from Sikkim Manipal Institute of Technology (SMU).

Does Sejalkumari have any certificates?

Sejalkumari has 6 certificates. Among them, these include: Being Well Microcredential, Certificate Of Introduction To GMP, and Communication Skills– Career Launchpad.

What is the availability of Sejalkumari?

Sejalkumari is immediately available full-time for suitable projects.

What is the rate of Sejalkumari?

Sejalkumari's rate depends on the specific project requirements. Please use the Meet button on the profile to schedule a meeting and discuss the details.