Aayushee Shah Email & Phone Number

Seattle, Wa, Us

•Compliance Research: Conduct research on relevant regulatory standards andrequirements, particularly in digital health and medical device software, to supportVirufy’s projects.•Documentation & Submission Support: Assist with preparing and organizingregulatory documentation, submission materials, and compliance reports.• Policy Tracking: Monitor changes in international regulatory policies impacting digitalhealth and medical device software.•Collaboration: Work closely with cross-functional teams, including research, productdevelopment, and clinical teams, to align project goals with regulatory compliance.• Process Improvement: Contribute ideas to streamline regulatory submission processesand compliance strategies.

Vadodara, Gujarat, India

• Serves patients by preparing medications, giving pharmacological information to multidisciplinary health care team, and monitoring patient drug therapies.• Became first pharmacy in organization to serve the government under my supervision.• Prepares medications by reviewing and interpreting physician orders and detecting therapeutic incompatibilities.• Dispenses medications by compounding, packaging, and labeling pharmaceuticals.• Controls medications by monitoring drug therapies; advising interventions.• Completes pharmacy operational requirements by organizing and directing technicians’ workflow, verifying their preparation and labeling of pharmaceuticals, and verifying order entries, charges, and inspections.• Provides pharmacological information by answering questions and requests of health care professionals and counseling patients on drug therapies.• Develops hospital staff’s pharmacological knowledge by participating in clinical programs and training pharmacy staff, students, interns, externs, residents, and health care professionals.• Complies with state and federal drug laws as regulated by the state board of pharmacy, the drug enforcement administration, and the food and drug administration by monitoring nursing unit inspection.• Maintains records for controlled substances and removes outdated and damaged drugs from the pharmacy inventory.• Supervises the work results of support personnel.• Maintains current registration, studies existing and new legislation, anticipates legislation, and advises management on needed actions.• Protects patients and technicians by adhering to infection-control protocols.• Maintains safe and clean working environment by complying with procedures, rules, and regulations.• Contributes to team effort by accomplishing related results as needed.

Vadodara, Gujarat, India

• Preparing, reviewing, approving and distributing the instructions for the production according to BMR (Batch Manufacturing Record), BPR (Batch Production Record).• Producing intermediate, APIs (Active Pharmaceutical Ingredients), the dosage form according to pre- approved instructions includes BMR, BPR, cleaning record.• Reviewing and ensuring all production batch records are completed.• Ensuring that all production deviations are reported and evaluated.• Operating manufacturing equipment and machinery to produce pharmaceutical components and products.• Documenting all production, keeping careful records of items produced and their weight.• Performing maintenance on manufacturing machines to prevent wear or damage.• Inspecting equipment prior to and following operation to identify any damages or inconsistencies, ensuring their safe functioning.

Halol, Gujarat, India

Master In Biomedical Regulatory Affairs

Bachelor Of Pharmacy - Bpharm, Pharmacy

Biology/Biological Sciences, General, B2