Ankit Mehta Email & Phone Number

Mississauga, On, Ca

Mississauga, On, Ca

Mississauga, Ontario, Canada

Mississauga, Ontario, Canada

Health Canada Licence: Annual renewal of Drug & Medical Device Establishment Licence (DEL & MDEL) including maintenance of GMP compliance for all foreign sites used to manufacture/ package/ label and test finished drug products and API.Audits: Lead and assist in regulatory/internal audits for GMP and Pharmacovigilance for drug products and medical devices. Perform vendor audits for CMO, GMP testing Labs and 3PL warehouses.eQMS Management: Implementation and maintenance of eQMS system (Salesforce, Dot Compliance) including designing processes lifecycle management, validation, regulatory compliance, training and manage eQMS as an ADMIN.SOP/Document Management: Ensure all SOPs remain up to date and maintain periodic reviews, conduct training for SOP revisions, compliance issues, GMP, GDP etc. Perform, review of APQR & Nitrosamine Risk Assessments for 90+ products and train staff on updated nitrosamine regulations on an ongoing basis.Deviation/Change Control Management: Write, review, approve, perform Impact Assessments, Risk Assessments, Action items, Effectiveness checks for Deviations/Change Controls and part of Change Control Board.Quality Agreements: Write, review, update, approve and maintain vendor/supplier quality agreements.

North York, Ontario, Canada

Reporting to Director of Quality and Regulatory.Complaint and CAPA Management: Manage Customer Complaints, CAPA, Investigations through QMS. Technical documentation and ensure proper retention of records and documents. Follow up on investigations and CAPA plans with respective departments and provide trending reports to Director of Quality.Device History Records Management: Write, Review, Device History Records, Physical / Visual Inspections for products, Final Release Reports, Preparation of Guides, Work Instructions and Job Travelers.eQMS Management: Develop, Implement, manage eQMS system (Cloudtheapp) on site as ADMIN USER, train staff on eQMS and validation.Regulatory Inspections: Support Regulatory Inspection readiness, process oversight and/or preparation of all responses to observations including any CAPA plans required for compliance. Support Internal audit quality system program from audit planning, implementation, feedback, re-audit as required.

Nova Scotia, Canada

Health Canada Security Cleared Personnel.Document Management: Write, review, authorize Change Controls, Deviations, Risk Analysis, Process Validations, Batch Release, Recalls, Investigations and CAPA effectiveness checks.Investigation: Lead investigations of facility floor issues, including root cause determination to ensure corrective action and set preventive measures.Supplier Management: Manage all external suppliers by performing external audits and approving all incoming raw materials, process materials, packaging materials and quality agreements with sites, laboratories etc.Training Management: Collaborate and deliver training to all departments to ensure compliance with Health Canada Cannabis Regulations.

Winnipeg, Manitoba, Canada

Testing of raw materials, finished product, in-process, stability, cleaning validation, batch/lot production runs, purified water, environmental and release of materials in-house.Development of in-house methods and validations, generate laboratory testing specifications for final release, trend analysis of stability studies, product development reports, annual product reviews, recognize out-of-specification or out-of-trend results and assist in the completion of lab investigation.

Mumbai, Maharashtra, India

Analyzed customer complaints, identify trends and tendencies with respect to lot, product and type of complaint and determine the cause, draft complaint reports, recommend changes based on investigations and trend analysis.Evaluate change request for equipment, primary, secondary components, processes, systems and various types of documents.Review product quality failure and non-compliance investigations, deviations and perform follow-up on corrective and preventive actions. Stability Program: Prepare stability protocols and execute, draft stability reports, trend analysis of data.

Ahmedabad, Gujarat, India

Post Graduate Diploma, Quality Assurance And Quality Control In Industry, A+

QA/QA in Pharmaceutical and Food Industry.

Master Of Science - Ms, Pharmaceutical Sciences, A

Research Thesis : Formulation and Optimization of Oro-dispersible tablet of a selective alpha adrenergic blocking agent. Publications.

Bachelor Of Pharmacy - Bpharm, Pharmaceutical Sciences, A

Activities and Societies: - Received 3rd prize for poster presentation at Rx festival of Indian Pharmaceutical Association (Provincial.