Mital K. Pancholi
Vadodara
Summary
Quality Assurance professional with 4+ years of experience in pharmaceutical QA and Analytical Method Validation. Skilled in SOP preparation, compliance documentation, audit readiness, and product SER (Structural Elucidation Report) preparation. Strong knowledge of GMP, regulatory requirements, and electronic record systems (PharmaCloud, DMS, LMS). Dedicated, detail‑oriented, and committed to ensuring product quality and compliance.
Overview
5
5
years of professional experience
Work History
Officer, QA Department
Oneiro Lifecare Pvt. Ltd.
12.2025 - Current
- Preparation, review, and approval of SOPs and quality documents.
- Review of BMRs, BPCRs, and analytical documents (Specifications, STP, ATDS).
- Preparation and review of Product SER (Structural Elucidation Report).
- Handling Change Control, Deviation, and CAPA documentation.
- Execution of audit compliance activities and support during regulatory inspections.
- Document issuance, retrieval, and archival in PharmaCloud and DMS.
- SOP preparation, correction, and controlled document management in DMS.
- Training management through LMS, including induction training for new joiners and tracking completion of all employee trainings.
- Coordination with cross‑functional teams for validation and compliance activities.
Jr. Research Associate, AMV Department
Ipca Laboratories
Ranu
09.2022 - 12.2025
- Analytical Method Validation (AMV) for pharmaceutical products.
- Preparation and review of validation protocols and reports.
- Document issuance, submission, and archival related to AMV activities.
- Handling of standard samples, reference standards, and working standards.
- Maintenance of standard sample inventory and documentation.
- Support in regulatory submissions with validated analytical data.
- Coordination with QA and QC teams for validation compliance.
Apprentice, QA Department
Oneiro Chemical Pvt. Ltd.
01.2021 - 01.2022
- Assisted in preparation of SOPs and QA documentation.
- Supported audit compliance activities and maintained document control for regulatory adherence.
- Issued and retrieved controlled documentation to ensure compliance.
- Exposure to stability study activities and preparation of stability protocols/reports.
- Learning and assisting in product quality review documentation.
- Participation in training sessions on GMP, GLP, and compliance practices.
- Assisted in preparation of logbooks, registers, and QA checklists.
- Supported QA team in initial audit readiness and compliance gap closure.
Education
M.Sc. - Organic Chemistry
Saurashtra University
01-2021
B.Sc. - Chemistry
Saurashtra University
01-2019
HSC -
G.S.H.E.B.
01-2016
SSC -
G.S.E.B.
01-2014
Skills
- Quality Assurance & Compliance
- SOP & Documentation Control
- BMR & BPCR review
- Deviation & CAPA Handling
- Change Control
- Audit preparation
- Risk Management
- Stability Study Documentation & Review
- Analytical Document Review
- Product SER (Structural Elucidation Report) Preparation
- Electronic Record Systems
- Cross-functional Team Coordination
Hobbies and Interests
- Reading
- Listening to Music
- Watching Movies
Languages
Gujarati
Native
Native
Hindi
Proficient (C2)
C2
English
Proficient (C2)
C2
Timeline
Officer, QA Department
Oneiro Lifecare Pvt. Ltd.
12.2025 - Current
Jr. Research Associate, AMV Department
Ipca Laboratories
09.2022 - 12.2025
Apprentice, QA Department
Oneiro Chemical Pvt. Ltd.
01.2021 - 01.2022
M.Sc. - Organic Chemistry
Saurashtra University
B.Sc. - Chemistry
Saurashtra University
HSC -
G.S.H.E.B.
SSC -
G.S.E.B.