Dipak Patel

Results-driven Quality Assurance professional with 9+ years of experience in API and Pharmaceutical Manufacturing. Extensive expertise in Quality Management System (QMS), GMP/cGMP, ICH Guidelines, Data Integrity (ALCOA+), Validation, Qualification, Regulatory Compliance, APQR, Risk Management, Change Control, CAPA, Deviation, OOS/OOT Investigation, Vendor Qualification, Batch Release, Documentation Control, and Internal & External Audits. Experienced in leading Quality Assurance teams, establishing robust quality systems, ensuring regulatory compliance, and driving continuous improvement initiatives.

Proven ability to successfully manage customer audits, regulatory inspections, validation activities, documentation systems, and cross-functional quality operations.

QA Manager at Adrhim Pharmaceutical LLP (2025-12 – Present)

• Lead complete Quality Assurance Department.
• Ensure compliance with GMP, cGMP, WHO-GMP and regulatory requirements.
• Manage Quality Management System.
• Review and approve SOPs, Specifications, Protocols and Reports.
• Lead Change Control, CAPA, Deviation and OOS investigations.
• Perform Batch Record Review and Batch Release.
• Conduct Internal, Vendor and Customer Audits.
• Lead Validation and Qualification activities.
• Ensure Data Integrity compliance.
• Conduct GMP Training Programs.

QA Manager at Adrhim Pharmaceutical LLP (2025-12 – Present)

• Strengthened documentation compliance across QA systems.
• Improved effectiveness of CAPA implementation.
• Enhanced audit readiness through systematic quality review.

QA Head at Nexus Pharmachem Pvt. Ltd. (2021-07 – 2025-11)

• Headed complete QA Department.
• Managed Documentation Control System.
• Led Validation Master Plan implementation.
• Managed APQR Program.
• Conducted Internal and External Audits.
• Reviewed Master Batch Records.
• Approved Validation Protocols and Reports.
• Managed Risk Assessment.
• Led Equipment Qualification.
• Oversaw Stability Program.
• Vendor Qualification and Audit.
• Regulatory Documentation.
• Team Management and Training.

QA Head at Nexus Pharmachem Pvt. Ltd. (2021-07 – 2025-11)

• Successfully maintained GMP Compliance.
• Led cross-functional quality improvement initiatives.
• Improved documentation accuracy.
• Strengthened Quality Management System.
• Successfully supported regulatory inspections.

QA Executive at Accent Microcell Pvt. Ltd. (2019-11 – 2021-07)

• Managed daily Quality Assurance activities in accordance with cGMP and regulatory requirements.
• Prepared, reviewed, and controlled SOPs, Specifications, Protocols, Reports, BMRs, BPRs, STPs, and other GMP documents.
• Performed Batch Manufacturing Record (BMR) and Batch Packaging Record (BPR) review before batch release.
• Executed and reviewed Change Controls, Deviations, Incidents, CAPA, and Risk Assessments.
• Coordinated Process Validation, Cleaning Validation, Equipment Qualification (IQ/OQ/PQ), and Analytical Method Validation activities.
• Conducted Line Clearance, In-process Checks, and Batch Release documentation review.
• Participated in Internal Audits, Vendor Audits, and Customer Audits and ensured timely closure of observations.
• Monitored Data Integrity (ALCOA+) and Good Documentation Practices (GDP) compliance.
• Supported Stability Studies and Annual Product Quality Review (APQR).
• Conducted GMP, GDP, and SOP training for production and QA personnel.

QA Executive at Accent Microcell Pvt. Ltd. (2019-11 – 2021-07)

• Improved documentation compliance through effective review and control systems.
• Successfully supported validation and qualification activities with timely completion.
• Contributed to successful internal and customer audits by ensuring GMP compliance.
• Reduced documentation errors through implementation of Good Documentation Practices.
• Strengthened CAPA and Deviation closure effectiveness by improving investigation quality.

QC Officer at IPCA Laboratories Limited (2018-02 – 2019-07)

• Performed Quality Assurance and Quality Control activities for API manufacturing.
• Conducted In-process Quality Checks and ensured compliance with approved specifications.
• Reviewed Raw Material, Packing Material, Intermediate, and Finished Product analytical records.
• Coordinated with Production, Warehouse, and QC departments to maintain smooth quality operations.
• Monitored compliance with GMP, GDP, SOPs, and regulatory requirements.
• Assisted in OOS, OOT, Deviation, Incident, and CAPA investigations.
• Reviewed laboratory documentation, analytical reports, and test records.
• Participated in Internal Audits and Regulatory Audit preparations.
• Ensured proper calibration and maintenance status of laboratory instruments.

QC Officer at IPCA Laboratories Limited (2018-02 – 2019-07)

• Maintained high GMP compliance during routine quality operations.
• Supported timely batch disposition through effective QA/QC coordination.
• Improved laboratory documentation accuracy and compliance.
• Assisted in successful completion of customer and internal audits.
• Contributed to continuous improvement of quality systems and documentation practices.

QC Officer at Exemed Pharmaceuticals (Zydus Group) (2016-11 – 2018-02)

• Performed analysis of Raw Materials, Intermediates, Finished Products, and Stability Samples as per approved specifications.
• Operated and maintained analytical instruments in wet section.
• Prepared analytical records, worksheets, and laboratory documentation in compliance with GDP and ALCOA+ principles.
• Performed calibration and routine verification of laboratory instruments.
• Participated in Method Validation, Method Transfer, and Stability Studies.
• Assisted in OOS, OOT, Laboratory Incidents, and Root Cause Investigations.
• Ensured laboratory compliance with GMP, GLP, and Data Integrity requirements.
• Maintained proper handling and storage of Reference Standards and Chemicals.
• Supported Internal Audits and Regulatory Inspection readiness.

QC Officer at Exemed Pharmaceuticals (Zydus Group) (2016-11 – 2018-02)

• Successfully performed routine quality testing with high accuracy and compliance.
• Maintained laboratory documentation in accordance with GMP and Data Integrity requirements.
• Supported timely release of Raw Materials and Finished Products.
• Improved analytical documentation accuracy through strict adherence to Good Documentation Practices.
• Contributed to maintaining audit-ready laboratory operations.

Master in Science in Chemistry – Singhania University (2023)

Bachelor of Science in Chemistry – HNGU University (2014)

XIIth Science – GSHSEB Board (2011)

Xth Secondary School – GSEB Board (2009)