Bhumi Patel

Quality Assurance Officer with over 3 years of experience in pharmaceutical manufacturing within GMP-regulated environments. Experienced in Quality Management Systems (QMS), GMP documentation, document control, batch record review, SOP management, CAPA, deviation handling, change control, training coordination, and regulatory compliance. Proven ability to support internal and international regulatory audits, including WHO-GMP, Korean, and Philippines FDA inspections.

Detail-oriented, organised, and committed to maintaining product quality and regulatory compliance.

QA Documentation Assistant - SOXA Formulation & Research Pvt. Ltd. - Himmatnagar, India

(2026-01 - 2026-05)

• Prepared, reviewed, and controlled GMP documents, including SOPs, protocols, reports, and formats.
• Managed document issuance, revision, archival, and retrieval in accordance with document control procedures.
• Ensured compliance with Good Documentation Practices (GDP) and Quality Management System (QMS) requirements.
• Supported QA documentation activities during internal and external audits.

QA Officer - West Coast Pharmaceutical Works Ltd. - Ahmedabad, India

(2023-06 - 2026-01)

• Reviewed Batch Manufacturing Records (BMRs) for accuracy, completeness, and GMP compliance before batch release.
• Prepared, reviewed, and controlled SOPs, protocols, reports, specifications, and quality documents.
• Managed document control activities, including issuance, revision, distribution, and archival.
• Supported CAPA implementation and monitored the effectiveness of corrective and preventive actions.
• Reviewed hold time study protocols and reports.
• Coordinated GMP training programmes and maintained employee training records.
• Assisted with deviation investigations and change control documentation.
• Participated in internal audits and regulatory inspections.
• Supported WHO-GMP, Korean, and Philippines FDA audits by preparing documentation, coordinating audit activities, and providing compliance evidence.
• Assisted in responding to audit observations through root cause analysis, CAPA preparation, and effectiveness verification.
• Ensured compliance with GMP, GDP, and company quality standards.

Master of Science (M.Sc.) - Chemistry - Silver Oak University (2021 - 2023)

Bachelor of Science (B.Sc.) - Chemistry - Hemchandracharya North Gujarat University (HNGU) (2018 - 2021)