Roshani Hedapara

Results-oriented Quality Assurance professional with over 12+ years of experience in Active Pharmaceutical Ingredients (API), and Life Science industries. Managed and developed a team of 26+ professionals, fostering a culture of quality and continuous improvement. Successfully led and completed 15+ vendor audits, including audit planning, execution, preparation and compilation of comprehensive vendor audit reports, and CAPA review and effectiveness assessment.

Successfully participated in and supported 15+ global regulatory and customer audits, including USFDA, EDQM, PMDA, WHO-GMP, ANVISA, COFEPRIS, Russian FDA, FAMHP, Korean FDA and GYEMSZI.

Quality Head at Amsal Chem Pvt. Ltd. (2026-02 – 2026-07)

Previous Position: QA Manager. Regulatory Approval: WHO-GMP (Geneva), EDQM

• Overall Quality Management System implementation and maintenance accordance with respective regulatory.
• Resolution of day-to-day challenges.
• Regulatory inspection readiness and audit management.
• Ensure compliance with cGMP regulations.
• Approved the SOPs, specifications, BMR and other master documents.
• Regulatory & Customer Audit/Query & Compliance and their response. Review, Approve of technical quality agreement.
• Handling and execution of Validation (Process, Cleaning and Method) and qualification activity.
• Handling of Vendor Development, qualification, re-qualification.
• Management of APQR activities.
• Conduction audit as auditee as well as auditor for Internal & External Audits.
• Approval of stability summary.
• Management review and continuous improvement initiatives.
• Change Control, Deviation, Market complaint, CAPA, OOS and their Risk Management.
• Evaluate rejection trends, complaints, deviations, CAPA effectiveness, and other quality metrics.
• Lead and handle Management Review Meeting.
• Documentation & Review and Approve like SMF, VMP, BMR, SOPs etc.
• Training & Train staff on GMP, GDP, SOPs, and quality standards.
• Implement Quality Risk Management (QRM) principles.
• Review and evaluate the risk of Nitrosamine Impurity, Element impurity, Product along with cross functional team.
• Audit Trial of QC instruments.
• Conducting Mock recall, transport validation study.

Senior Executive – Quality Assurance at Umedica Laboratories Pvt. Ltd. (Formally Known as Amoli Organics Pvt. Ltd.) (2023-07 – 2026-01)

Regulatory Approval: USFDA | EDQM | PMDA | ANVISA | COFEPRIS | WHO-GMP | Russian FDA | Korean FDA

• Implement Quality Risk Management (QRM) principles.
• Review and evaluate the risk of Nitrosamine Impurity, Element impurity, Product along with cross functional team.
• Handling of Regulatory queries.
• Conduction audit as auditee as well as auditor for Internal & External Audits.
• Handling of Vendor Development, qualification, re-qualification.
• Handling and execution of Process and Cleaning validation activities.
• Cleaning hold time and dirty hold time, Continuous Cleaning & Process Verifications.
• Regulatory & Customer Audit/Query & Compliance and their response. Review of technical quality agreement. Part of the business development activity like provide and review the questionnaire, declarations and give query response etc.
• Regulatory inspection readiness and audit management.
• Review of APQR.
• Management of Hold time study and stability study from sample arrangement to summary.

Senior Executive – Quality Assurance at Bajaj Healthcare Ltd. (2022-05 – 2023-02)

Regulatory Approval: USFDA | EDQM | WHO-GMP

• Change Control, Deviation, Market complaint, CAPA, OOS and their Risk Management.
• Handling and execution of Validation Process, Cleaning.

Officer To Executive - Quality Assurance at Amoli Organics Pvt. Ltd. (2015-12 – 2022-05)

Regulatory Approval: USFDA | EDQM | PMDA | ANVISA | COFEPRIS | WHO-GMP | Russian FDA | Korean FDA

• Handling and execution of Process and Cleaning validation activities.
• Cleaning hold time and dirty hold time, Continuous Cleaning Verifications.
• Handling of Vendor Development, qualification, re-qualification.
• Review of the Technology Transfer Documents & Handling of DQA activities.
• Regulatory & Customer Audit/Query & Compliance and their response. Review of technical quality agreement. Part of the business development activity like provide and review the questionnaire, declarations and give query response etc.
• Regulatory inspection readiness and audit management.
• Handling of Change control activities.
• Management of Hold time study and stability study from sample arrangement to summary.
• Review the APQR.
• Audit trial of QC.

Trainee To Jr. Executive - Quality Assurance at Adroit Pharmachem Pvt. Ltd. (2014-06 – 2015-08)

Regulatory Approval: WHO-GMP

• Daily IPQA activity, to give Line Clearance in Production.
• Sampling Activity.
• Batch Release and dispatch activity including BMR and analysis protocol review.
• Document Data Control.
• Issuance of BMRs, SOPs, Formats, Labels and all controlled Documents and archiving of Document.

Advance post graduate Diploma in regulatory Affairs in API & Formulations – Institute of Pharmaceutical Management (2024-12 – 2025-06)

Pharma in Quality Assurance – Gujarat Technology University (2011 – 2013)

B. Pharm – Bhavnagar University (2006 – 2010)

H.S.C. – G.S.H.S.E.B (2006-03)

S.S.C. – G.S.E.B (2004-03)