Ritesh Shinde

As a dedicated and detail-oriented Quality Assurance professional in the pharmaceutical industry, I have a proven track record of ensuring product safety, regulatory compliance, and overall quality control. My expertise lies in implementing and maintaining robust quality systems, conducting rigorous audits and inspections, and collaborating with cross-functional teams to drive continuous improvement. With a strong foundation in Good Manufacturing Practices (GMP) and industry-specific regulations, I have consistently contributed to the success of pharmaceutical organizations.

Senior Quality Assurance Officer - ADVY BIOSCIENCE PVT LTD - Thane

(2025-03)

• Managed QMS activities including deviation, CAPA, OOS, Change Control and quality incidents under ISO 9001 standards.
• Ensured compliance with GMP, GDP, and data integrity practices across operations.
• Coordinated with Production and QC teams for investigation closure and CAPA implementation.
• Supported New Product Development (NDP) and Technology Transfer.
• Preparation of custom clearance documents and customer requirements documents.
• Reviewed BMRs, COA, STP, logbooks, and QC documents for accuracy and compliance.
• Performed IPQA checks, Gemba walks, line clearance, and in-process verification activities.
• Assisted in internal and customer audits by coordinating QA documentation and compliance records.
• Supported equipment qualification, process validation, and documentation review activities.
• Maintained issuance, archival, retrieval, and reconciliation of controlled documents.
• Maintained Excel-based QA trackers for effective documentation control and monitoring.
• Software use ISOxpress and NetSuite for ERP& COA release.

Quality Assurance officer - Cipla pharmaceutical Pvt Ltd. (Hi-Tech Info) - Pune

(2024-04 - 2025-03)

• Audit trail report preparation, Document handling and Inprocess Checking of process& Products.
• Prepare and executed documentation as per SOP’s, including IT system validations and maintenance record.
• Document Compliance, Quality Management System, Change Control, Deviation Handling, and Pending observation review.
• Handled data archival and maintained logbooks. Managed user access (ID creation, deactivation, password resets, etc.)
• Performed data backup, restoration, and validation. Implemented desktop policies (privileges, roles, groups).
• Verified system date and time settings. Ensured compliance during internal, customer, and regulatory audits.
• Coordinated with vendors for troubleshooting manufacturing systems.
• Assisted with equipment qualification and software validation.

Quality Assurance Officer - Aditi Pharmaceuticals (Injectable) Pvt Ltd - Solapur, India

(2022-04 - 2024-01)

• Managed BMR and BPR documentation.
• Conducted in-process quality checks.
• Took line clearance of manufacturing, filling, and packing areas.
• Conducted visual inspections.
• Led a review process, reducing deviations by 30% and improving efficiency.
• Implemented quality control measures, reducing errors by 25% and ensuring compliance.
• Sampled and tested materials and finished products.
• Documented and reported deviations.
• Collaborated with production teams to resolve quality issues.
• Ensured regulatory compliance (FDA, EMA).
• Participated in validation, qualification, and calibration.
• Assisted in developing and maintaining quality systems, SAP handling (BMR Print), APQR documentation
• Handled all activity of IPQA

B Pharm - NET Pharmacy College, Raichur, Rajiv Gandhi University of Health Sciences, Karnataka (2022)

HSC - C.B Khedgi College Akkalkot, Pune Board University, Maharashtra (2017)

SSC - Shri Shahaji High School, Akkalkot, Pune Board University, Maharashtra (2015)