Yogesh Bansod

Dynamic and detail-oriented Quality Assurance Professional with over 12 years of comprehensive experience in the pharmaceutical industry. Demonstrated expertise in cGMP compliance and regulatory frameworks across diverse dosage forms including Oral Solid Dosage (OSD), Oral Liquids, and Injectables. Extensive experience in leading Quality Management System (QMS) functions: proficient in the review and handling of Change Controls, Deviations, Incidents, CAPA, and Market Complaints.

Strong background in audit readiness, documentation review, and ensuring adherence to global regulatory standards (e.g., WHO, USFDA, EU-GMP). Adept at leading cross-functional teams, driving quality improvements, and fostering a culture of compliance and continuous improvement. Known for strategic thinking, excellent communication, and organizational skills, with a proven ability to align quality initiatives with business objectives.

Executive CQA - Crescent Pharma UK (India Office)

(2025-12)

• Managing Quality Management System (QMS) activities for 10 Contract Manufacturing Organization (CMO) sites.
• Handling Change Controls and Deviations through QMS software (Master Control), ensuring compliance with regulatory and internal quality requirements.
• Reviewing Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR) of finished products to ensure accuracy, completeness, and compliance.
• Tracking and monitoring Corrective and Preventive Actions (CAPA) across CMO sites to ensure timely closure and effectiveness.
• Reviewing risk and impact assessments and ensuring effective risk communication in accordance with quality risk management principles.
• Site Audit of CMO site.

Senior Executive CQA - Naprod Life Sciences Pvt. Ltd - Boisar, Palghar

(2022-06 - 2025-12)

Plant approval: INVIMA (Colombia), EU, ANVISA (Brazil), Third Party Audit

• Handling of Change Controls and Deviations through the QMS software Master Control Software
• Review of risk/impact assessment & risk communication.
• Evaluation of Nitrosamine and Elemental impurities in Finished Formulation.
• Artwork Review
• To Check and perform Supply Chain Management (SCM) related Activities and Compliances. Perform investigation with the coordination with cross functional team for deviation.
• Handling of Market complaints.
• Lead and executed vendor qualification activities, conducting over 40 audits covering APIs, excipients, and primary packaging materials — including 7 on-site audits at domestic API manufacturers.
• Tracking of vendor's qualification, Handling of Material complaint (Supplier corrective action request), Vendor's site audit QMS activity related to vendor qualification
• Handling Quality Related activity of Third party and Loan licensing site.

QA Executive - IPCA Laboratories Ltd - Boisar, Palghar

(2021-11 - 2022-06)

Plant approval: WHO, Kenya, Uganda

• Routine Manufacturing compliances & in-process activities.
• Review and compliance of online e BMR and SOP's.
• Implementation of GMP, Quality Systems and procedures during the Manufacturing Process.
• Handling of Change Controls and Deviations through the QMS software Trackwise
• Review of risk/impact assessment & risk communication.
• Line Clearance of On-going Products for Dispensing, Manufacturing and Packing Operations.
• To Check and perform SCM related Activities and Compliances.
• Perform investigation with the coordination with cross functional team for deviation.
• Handling of Market complaints and to assist senior Site technical committee member in its related investigation.
• Annual Product Quality Review (APQR).
• On job training to IPQA and Production team on cGMP

QA Senior Officer - Intas Pharmaceuticals Ltd. - Matoda, Ahmedabad

(2017-04 - 2021-11)

Plant approval: USFDA, MHRA, TGA

• Routine Manufacturing compliances & in-process activities.
• Review and compliance of online e BMR and SOP's.
• Implementation of cGMP, Quality Systems and procedures during the Manufacturing Process.
• Handling of Change Controls and Deviations through the QMS software Q-edge.
• Review of risk/ impact assessment & risk communication.
• Line Clearance of On-going Products for Dispensing, Manufacturing and Packing Operations.
• To Check and perform SAP related Activities and Compliances.
• Perform investigation with the coordination with cross functional team for deviation.
• Handling of Market complaints and to assist senior of cross functional team (CFT) member in its related investigation.

QA Junior officer - Macleod Pharmaceutical Ltd - Sarigam - Vapi, Gujarat

(2016-04 - 2017-03)

Plant approval: USFDA, WHO

• Routine Manufacturing compliances & in-process activities.
• Communication to Superiors related to the Quality Assurance Activities on Daily basis.
• Review and compliance of online BMR and SOP's.
• Implementation of GMP, Quality Systems and procedures during the Manufacturing Process.
• Involved in QMS Activities like change control, deviation & CAPA.
• Involved in Process Validation Activities and Data Compilation.
• Annual Product Quality Review (APQR).
• Responsible for coordinating day to day activities of preparing, issuing, reviewing, maintaining, archiving and destruction of various Quality documents and maintaining the QA record room.

Quality Assurance Junior officer - Indoco Remedies Ltd - Waluj, Aurangabad

(2014-08 - 2016-03)

Plant approval: WHO, NDA Uganda, Kenya

• Routine Manufacturing compliances & in-process activities.
• Communication to Superiors related to the Quality Assurance Activities on Daily basis.
• Review and compliance of online BMR and SOP's.
• Implementation of GMP, Quality Systems and procedures during the Manufacturing Process.
• Involved in QMS Activities like change control, deviation & CAPA.
• Involved in Process Validation Activities and Data Compilation

Trainee - Sky Biotech Pharmaceutical Pvt. - Georai Tanda, Aurangabad

(2013-12 - 2014-07)

Plant approval: WHO

• Routine Manufacturing compliances, in-process control for solid dosage facility.
• Communication to Superiors related to the Manufacturing Assurance Activities on Daily basis.
• Review and compliance of online BPR's, Manufacturing Process and SOP's.
• Implementation of GMP, Quality Systems and procedures during the Manufacturing Process.
• Involve in Cleaning Validation like swab sampling and its Documentation.
• Line Clearance of On-going Products for Dispensing, Manufacturing and Packing Operations.
• Involve for Process Validation Activities and Data Compilation.
• Finished Product, Stability and Hold Time Study Sample Collection for Analysis.

PGDM - Goa Institute of Management

M. Pharm - QAT - Pune (2013)

B. Pharm - Dr. BAMU (2011)