• Facilitate the lifecycle of master documents of GLP, cGMP, and internal audits; (including SOPs, validation IQ, OQ & PQs, test methods, protocols, reports, specifications, memos, etc.) by functioning as a document workflow coordinator.• Coordinate in routine audits (Internal audit, Partner audit) of maintained documents to ensure that all documents were accounted for and current in MyQumas (EDMS).• Support audit and inspection readiness response activities for Federal Drug Administration (FDA), and other health authority inspections.• Prepares audit reports and performs follow-up to obtain resolutions that are compliant with regulations and satisfactory to all parties.• Participate in the document change control process, ensuring proper review, approval, and implementation of changes in a controlled manner.• Manage and document Corrective and Preventive Actions (CAPA) related to quality deviations, ensuring proper tracking, resolution, and closure of CAPA.• Responsible for issuing, executing, closing, and filling control documentation for the site (including logbooks, procedures, test methods, specifications, batch documentation, and labels) and maintained an issuance log.• Assured applicable site personnel were adequately trained in the principles, policies, and procedures of the document management system.• Assist in developing strategies to increase quality satisfaction levels.

• Engaged in post-marketing survelliance (Phase-IV Clinical trails) of weight loss medication WEGOVY.• Screened over 1000 patient records, databases, and physician referrals to identify prospective candidates for research study.• Collected data and followed research protocols, operations manuals, and case report form requirements.• Responsible for data cleaning, data management, and analysis utilizing skills in SQL, SAS, or R.• Monitored, analyzed, and evaluated data for the safety of the Patient.• Obtained and documented patient medical history, vital signs and current complaints at intake.• Developed and implemented risk minimization strategies, including Risk Evaluation and Mitigation Strategies (REMS).• Followed informed consent processes and maintained records of all day-to-day activities.• Collaborated with medical and administrative personnel to maintain patient-focused, engaging and compassionate environment.

• Critical patient monitoring and reviews patient profile/chart to identify, prevent, or mitigate drug-related problems, improper drug or dose selection, sub therapeutic dosage, over dosage, adverse drug reactions, drug interactions, failure to receive drugs, untreated indications, medication use without an indication, and treatment failures. • Established and maintained long and short-term goals for quality improvement program, monitoring an documenting quality improvement projects for progress in meeting QI goals.• Participated in quality improvement initiatives related to medication use processes, working to enhance the overall quality of pharmaceutical care.• Lead a quality management program and implemented evidence based- interventions following regulatory compliance initiatives designed to improve medication use process.• Evaluated patient histories to assess medication compliance and assure drug utilization activities are aligned with patient care needs.• Educated patients on possible drug interactions, potential side effects, and optimal methods of administration.• Provides discharge medication review, reconciliation, and counseling as appropriate.• Maintained accurate and complete clinical documentation of pharmaceutical care interventions, ensuring compliance with regulatory standards.• Coordinated with medical providers, laboratories, and care givers and assure continuity of pharmaceutical care by patient centered recommendations.• Overall, oversee the pharmacy operations and technician practices as per regulatory guidelines.

o Educated patients on possible drug interactions, potential side effects, and optimal methods of administration.o Displayed patient-oriented and comprehensive clinical pharmacy services and pharmaceutical care. o Prepared SOAP (subjective, analytical, evaluation and planning) analysis for different cases; provided a pharmaceutical treatment plan.o Expertise in Bio-medical literature search by using different databases such as Micromedex and Lexicomp for the provision of drug information to healthcare professionals.o Prepared packaging and labels for prescriptions, verifying accuracy of dosage, side effects, interactions, and refill instructions.