Sanjivani Shirke

• Ensure manufacturing compliance with FDA cGMP (21 CFR Parts 210/211 and Part 111) across OTC drug and dietary supplement product lines. • Author and maintain SOPs, Master Batch Records (MBRs), and change controls within the QMS — currently overseeing 10+ active BMR revisions across commercial products. • Conduct labeling compliance reviews per Drug Facts and Supplement Facts requirements (21 CFR Part 201). • Perform regulatory impact assessments for manufacturing, labeling, and formulation changes per applicable 21 CFR regulations. • Lead deviation investigations, CAPA implementation, and validation activities across 3 commercial product lines using risk-based quality principles. • Coordinate FDA inspection readiness and compliance audits across manufacturing and quality operations. • Manage product complaint evaluation, documentation, and investigation with appropriate regulatory reporting per QMS procedures.

*Assisted in formulation development of OTC tablet and capsule products during laboratory and pilot-scale trials. * Performed weighing, blending, granulation, lubrication, compression, and encapsulation activities. * Supported optimization of formulations to improve dissolution, hardness, friability, and content uniformity. * Conducted pre-compression and post-compression evaluations including bulk density, flow properties, tablet weight variation, hardness, friability, and disintegration testing. * Assisted in scale-up activities for tablet and capsule manufacturing under cGMP guidelines. * Worked with equipment such as V-blenders, rapid mixers, tablet compression machines, capsule filling machines, and coating pans. * Supported troubleshooting of manufacturing issues including sticking, picking, capping, and dissolution failures. * Prepared and maintained batch records, formulation development reports, and SOP documentation. * Assisted in stability study sample preparation and monitoring according to ICH guidelines. * Collaborated with Production, QA, and QC teams to ensure compliance with FDA and GMP requirements. * Evaluated excipients and raw materials for compatibility and formulation performance. * Participated in process optimization and continuous improvement activities for solid oral dosage forms.

Supported undergraduate students in understanding foundational chemistry concepts and laboratory techniques, aligning closely with my expertise in pharmaceutics. Prepared and managed lab materials, ensured adherence to safety protocols, and provided individualized guidance to enhance practical skills. This role strengthened my ability to bridge theoretical knowledge with hands-on application, a critical component of my master’s program in pharmaceutics.

Review and enter Individual Case Safety Reports (ICSRs) in the ARISg/LifeSphere MultiVigilance (LSMV) database while ensuring compliance with SOPs and Health Authority deadlines. Evaluate case seriousness accurately, prioritize cases, and meticulously capture essential drug safety data from source documents in LSMV, encompassing adverse events, suspect drugs, reporter and patient details, medical history, lab results, and medication specifics. Perform MedDRA coding for events, medical history, indications, and lab tests; conduct coding for suspect drugs using Product and World Health Organization Drug Dictionaries. Create concise adverse event report summaries using appropriate safety templates, maintaining the medical context and chronological order of safety information. Recognize discrepancies by requesting missing information or translations, ensuring completeness before submission to health authorities. Initiate communication and follow-ups with healthcare professionals, patients, vendors, etc., to gather supplementary case details. Manage various report types including clinical trials, literature, non-interventional studies, spontaneous, license partner, health authority, and courtesy letter reports. Review literature articles and generate Individual Case Safety Reports (ICSRs) as required. Provide mentorship to new staff in case processing and conduct necessary training sessions. Simultaneously manage eSAE Clinical Trial case processing, handling intake and full data entry within a unified workflow.

Arrange various medicines and surgical equipment in order within the In-patient Pharmacy Department (IPD). Label drugs with color coding based on the nature/class of the drug (e.g., Narcotics labeled in red, etc). Dispense medication to Nurses and Patients as required. Maintain a daily record of all medications dispensed.

Graduated with a strong foundation in pharmaceutical sciences and cosmetic product formulation. Gained hands-on experience in drug manufacturing processes, quality control, regulatory compliance, and research methodologies. Prepared to contribute effectively to pharmaceutical production and innovative R&D projects.