Shabihul Hasan Qadari

Quality Assurance Executive @SUN PHARMA

Mohali district, IN

Experienced and detail-oriented quality professional with a strong track record of developing and implementing quality strategies aligned with business goals and regulatory expectations. Adept at fostering a quality-first mindset across teams and ensuring consistent delivery of high-standard products and services. Regulatory & Market Query and Response Expertise:Deep knowledge of EU, ICH, WHO, FDA, and other global regulatory guidelines.Quality Assurance & Regulatory Compliance Expert | cGMP | QMS | Global Audits | CAPA | Validation.Proficient in Quality Management Systems (QMS), Batch Usage Decisions, Product Release/Disposition, and Stability Studies.Skilled in handling customer and regulatory complaints, product quality investigations, and change control reviewsExperienced in Transportation validation, Product recalls, Product Return, Temperature mapping, and Trending Quality data. Operational Excellence:Successfully managed multiple workflows while applying optimal QA standards to enhance business performance and Business Development. Led investigations for OOS, OOT, OOC, and market/customer queries with precision and complianceExecuted stability studies, process validations, and equipment qualifications under cGMP, ICH, and PIC/S guidelinesOversaw SOP reviews, deviation management, and regulatory filings Audit & Compliance Leadership:Hands-on experience in global regulatory audits: EU (3x), USFDA (2x), TGA (2x), WHO, ANVISA, PMDA, COFEPRIS, KFDServed as SME, scribe, and runner across organizations, currently contributing as a Subject Matter Expert🤝 Team Leadership & Collaboration:Successfully led and coached Qualified Persons and multicultural teams to drive operational successBuilt strong industry knowledge around equipment and process validation expectationsImplemented CAPA and continuous improvement cycles to elevate process performance and compliance

Jamia Millia Islamia

Master’s Degree, Biology Technician/Biotechnology Laboratory Technician

Jamia Millia Islamia

Master's degree, Biotechnology