Position Summary: Document, investigate and implement corrective actions for Quality events.Areas of responsibility:• Quality Events:- Initiate and document deviations, NCMRs and CAPAs.- Investigation of deviations, NCMRs, Customer Complaints, CAPAs- Perform complete risk assessment and root cause analysis - Establish necessary Corrective and Preventive Actions related to all Quality Events- Track and trend quality events• Initiation, collaboration and approval of change request forms for documentation in an online quality management system (Mastercontrol).

Position Summary: Participate in the activities related to the creation, review and approval of documentation for US, Canadian and Australian sites ensuring compliance with regulatory (Health Canada, FDA and TGA), GMP, and ISO requirements. Areas of responsibility:• Creating, updating, review and approval of:- English and French safety data sheets for chemical products to the 16 section GHS format which are compliant with regulatory requirements for US (OSHA), Canada (WHMIS) and Australia (WHS).- Internal raw material specifications according to USP, BP, EP, and FCC monographs or manufacturer’s certificates of analysis.- Internal certificates of analysis.- Bilingual label text for chemical products and devices for Canadian site.• Initiation, collaboration and approval of change request forms for documentation in an online quality management system (Mastercontrol).• Maintenance of vendor qualification list for raw materials.

Position Summary: 6 month contract. Participate in activities related to the documentation for the quality unit for raw materials, finished products and stability studies. Areas of responsibility:• Prepare requisitions, certificates of analysis or summaries and the updating of trends or regressions for raw materials, finished products and stability studies.• Coordinate the sampling and testing of raw materials, finished products and stability samples and follow-up on out of trend or out of specification results.• Creating and updating of internal raw material specifications according to USP, BP, EP, and FCC monographs or manufacturer’s certificates of analysis.• Initiation, execution and follow-up of change control forms for raw materials, finished products and stability studies.• Coordinate the testing and comparison of raw materials for vendor qualification.• Coordination and verification of daily, weekly and quarterly water monitoring and testing for internal purified water.• Filing of all active and obsolete GMP documentation associated to the above tasks.