Devanshi Desai Email & Phone Number

Oakville, Ontario, Canada

Oakville, Ontario, Canada

Oakville, Ontario, Canada

Manage multi-component Vendors liaising with internal and external stakeholders to plan, implement and execute Finished Product, API, and packaging component batch release documents• Review CoA, CoC/M's, sterile batch manufacturing records, packaging records, process validation protocols and other release related documents• Lead Quality meetings, set targets and timelines for multiple projects simultaneously respond to daily compliance enquiries with Health of Canada• Assist QA management in the development/revision of QA procedures and acting as team lead as required• Support Quality team and actively participate in deviation, change control and CAPA program• Support operation team to ensure that product disposition will be done on timely manner with GMP compliance • Engaged positively with each customer, providing professional and polite support for sales and service needs• Support quality team during regulatory inspection and internal audit• Maintain RFT matrix and provide data to project management and compliance team

Brampton, Ontario, Canada

Perform Routine line clearance/inspections on the packaging lines.Ensure routine compliance of day to day activities on the packaging area.Collect samples for retention and routine testing, and ensure all relevant paperwork is complete. Submit samples to laboratory in a timely manner to meet business requirements.Issuance, monitoring, review and archival of production log books.Perform QA review for Magnahelic gauges and temperature monitoring in the GMP area and prepare EM reports.Perform routine inspection of GMP areas and provide coaching to improve compliance and GMP behavior.Provide continuous support to packaging line, assess issues in GMP manner and provide real time solutions.Initiate incident reports related to production areas, as required.Provide floor support to investigation team and perform QA review of event reports, as required.Oversee Temperature Monitoring systems for GMP areas; Temp Tale Maintenance, identification (CPMS database), configuration, installation and monthly data downloading and trending.Initiate product hold/reject notification requests.Record GMP observations on production floors on shift basis and communicate as required communication with IT, material management, investigation team, purchasing, packaging specialist and other department for GMP related concerns.

Scarborough, Toronto,Ontario

->Maintain paitent's history and records, verification of lab reports and investigation through EMR (Electronic Medical Record) software.->Consistently praised for efficient handling of administrative duties (e.g., answering phones, scheduling appointments, maintaining medical records, patient processing, billing and bookkeeping) that allowed doctors and nursing staff to focus on the health concerns of their patients->Ensured the cleanliness, sanitation and maintenance of all facilities, exam rooms and equipment->Assist physician during patient examinations

India

-Preparing, Maintaining, Managing and Tracking of all the Quality Management Documents like Change Controls, Deviations, Incidents, Out Of Specifications, Malfunction Reports, Risk Assessments,Handling market complaints and product recall as per cGMP Requirement,-Interact with regulatory affairs other staff for the submission of documents for dossier preparation to identify trends and nonconformance issues-Review batch records, data notebooks, instrument/equipment logbooks and formats.-Issuance, submission, distribution, retrieval, retention and destruction of various GMP documents and maintain respective formats.-Responsible for preparing the Standard Operating Procedures and ensuring the implementation, verification and review of the procedure in regards with GMP compliance -Responsible for reviewing of specification, sampling instructions, and standard test procedure of raw material to finished products.

M.Sc, Microbiology

Master Of Science