Tirth Shah

Regulatory Affairs & QA Associate | MSc RA (Northeastern University) | B.Pharm | GMP, ISO 13485, Health Canada | QA, CAPA, Submissions | Ex-Wipro

Scarborough, Ontario, Canada

About

Experience

  • Pharmacy Assistant at Milner Healthcare Pharmacy
    Jan 2026 - Present · 6 mos

  • Pharmacy Assistant at queen hansen pharmacy
    Feb 2024 - Sep 2024 · 8 mos

    Accepting, entering, processing and filling prescriptions accurately and efficiently through Kroll -Dealing with healthcare professionals, third party insurances and staff members. Assisting in inventory management. - Assisting pharmacist in all the situations as needed. -Answering phone calls and assisting the patient over the phone. -Processing payment and owing balance. - Worked on bottling, labelling, ordering, blistering, syrup filling. -Managing the workflow and billings for the blisters.

  • Business Development Manager at Costcon Healthcare LLP
    Feb 2023 - Nov 2023 · 10 mos

    Customer/ Client handling  Purchase and procurement of raw material (active ingredients)  Understanding client requirements.  Governmental documentation  Regulatory Documentation requirement  Marketing and sales  Team coordination and batch planning  Documentation for product approvals  Co-ordination with regulatory authorities for permissions and approval  Handling GMP approvals and audits  Compliance with GMP and SOPs for production planning and procurement  Co-ordination with QA team for required documents to submit BMRs

  • Associate at Wipro
    Mar 2022 - Feb 2023 · 1 yr

    Complaint handling for medical devices  Analysing the complaint received through the customers and various other platforms by working on Trackwise software.  Using the platforms like ARIS Global and ARGUS for running the surveillance.  Referring EU MDR for European markets for handling complaints and its compliance.  Analyzing the ICSR forms filled for surveillance to register the complaints.  Medical writing and literature review for the medical devices and the pharmacovigilance.  Training for the SME for running the process with skills and error-free.  Complaint evaluation and complaint investigation for medical devices and KPI evaluation for Quality check of the work