Bhoomi Patel

Dedicated Pharmaceutical Quality Assurance professional with over 11.10 years of experience in regulatory compliance, quality systems management and audit preparation. Proven expertise in handling Query Response, OOS/OOT investigations, CAPA management, APQR and ensuring adherence to cGMP, USFDA, MHRA and WHO standards. Skilled in statistical analysis and cross-functional team coordination to drive quality assurance.

Executive Quality Assurance - Torrent Pharmaceuticals Pvt. Ltd. - Chhatral

(2024-03)

• Handling customer and regulatory queries and ensured timely resolution.
• Managing document submissions to customers, international operations and R&D departments.
• Coordination with cross-functional teams to compile batch documentation and respond to quality and regulatory queries in line with regulatory standards.
• Managing the submissions of documents to the Regulatory Affairs department, coordinating with plant-based support functions to facilitate dossier preparation and regulatory submissions for the US and Brazil market.
• Reviewed full-scale manufacturing investigations for OOS (Out of Specification) and OOT (Out of Trend), including follow-ups, root cause analysis, recommended actions, conclusions, and closure.
• Perform trending analysis to identify recurring issues and potential quality risks.
• Conducted regression analysis and future trend prediction using Minitab, providing data-driven recommendations and investigation conclusions.
• Review CAPA closure reports, effectiveness evaluations, and CAPA extensions to ensure compliance and sustainability of corrective actions.
• Ensured effective implementation and verification of CAPA actions across departments.
• Prepared and reviewed OOT Trend and Quality Metrics for OOS and OOT performance monitoring.
• Prepared Management Review Meeting (MRM) presentations for CAPA status and effectiveness checks.
• Handling of Change Control and ensuring proper impact assessment and implementation.

Associate Quality - Baxter Pharmaceuticals India Pvt. Ltd. - Chacharvadi-vasna

(2016-06 - 2024-02)

• APQR preparation and review in compliance with regulatory requirements.
• Change Control management including impact assessment, execution, closure, and effectiveness verification.
• Statistical analysis using Minitab for trend analysis and quality data evaluation.
• Monitoring Continuous Process Verification (CPV) and preparation of CPV reports.
• Review of data from batch documents (BMR, BPR, IPPT, FP) and batch summary records.
• Preparation, review and revision of SOP.
• Review of QMS compliance for PQR compilation.
• Review and compilation of OOS and OOT investigations with CAPA and effectiveness checks for PQR compilation.
• Vendor quality management data review including SCAR, RM/PM rejections, and commitments for PQR compilation.
• Review of product wise deviations, CCN, market complaints, recalls, returns, and batch cancellations for PQR compilation.
• Review of qualification, validation, and stability data for PQR compilation.
• Maintenance of QMS and product summary reports for management review.

Compliance Trainee - Mylan Laboratories Ltd. - Pharmasez

(2015-03 - 2016-06)

• Change Control management including initiation, risk and impact assessment, cross-functional coordination, execution, closure, and effectiveness verification.
• Deviation Management System handling: logging, tracking, investigation, impact assessment, CAPA discussion, review and closure.
• Investigation and reporting of non-compliances and quality incidents.
• Review of ratifications and correction of documentation errors.
• Monitoring of cGMP compliance and plant housekeeping activities.
• Preparation and revision of BMR and BPR.
• Review of BMR and BPR in line with approved standards.
• Documentation control including issuance, distribution, retrieval, archival, and destruction of controlled documents.
• Preparation and review of Standard Operating Procedures (SOPs).
• Handling BOM changes, recipe creation, and BOM creation requests.
• Verification of BOM and BMR/BPR against TTD-M and TTD-P.
• Review of artwork against TTD-P for compliance.

Compliance Trainee - Trio Remedies Pvt. Ltd

(2014-08 - 2015-02)

• Change Control management including initiation, risk and impact assessment, cross-functional coordination, execution, closure, and effectiveness verification.
• Deviation Management System handling: logging, tracking, investigation, impact assessment, CAPA discussion, review and closure.
• Investigation and reporting of non-compliances and quality incidents.
• Review of ratifications and correction of documentation errors.
• Monitoring of cGMP compliance and plant housekeeping activities.
• Preparation and revision of BMR and BPR.
• Review of BMR and BPR in line with approved standards.
• Documentation control including issuance, distribution, retrieval, archival, and destruction of controlled documents.
• Preparation and review of Standard Operating Procedures (SOPs).
• Handling BOM changes, recipe creation, and BOM creation requests.
• Verification of BOM and BMR/BPR against TTD-M and TTD-P.
• Review of artwork against TTD-P for compliance.

Bachelor's degree - L. J. Institute of Pharmacy, GTU (2010 - 2014)

HSC - Muktjivan High School (2010 - 2010)

SSC - BVD High School (2008 - 2008)