Quality Assurance Coordinator

1 week ago

Old Toronto, Canada Produtos Full time

Nordic Pharma is a mid-size privately-owned international pharmaceutical company which focuses on the development and commercialization of niche hospital and orphan products to address unmet medical needs. Nordic Pharma’s expertise relies on the development and sales of its own products, but also on partner products acquired at various stages of development. Today, Nordic Pharma has a range of highly specialized proprietary and inlicensed products in the following therapeutic areas: Rheumatology, Women’s Health and Critical Care (Anaesthesia, Haematology, Oncology).Nordic Pharma’s values of Commitment, Ambition, Respect, Reliability, Integrity and Agility describe our culture and standards and guide us in our way of working. JOB TITLE: Quality Assurance Coordinator DEPARTMENT: Quality Assurance REPORTING TO: Manager, Quality and Supply Chain LOCATION: Toronto, ONGeneral summary of role:Manage and perform tasks to ensure Celopharma Drug Establishment license is kept currentPerform review and approvals for critical Quality documentsPerform drug product review and releasesManagement of critical quality management systems (Change Control, Complaint and Deviation process; CAPA process)Electronic Data Management Systems-local coordinator for training, management of rights, document creation, main point of contact with corporate and Nordic AAP employee)Essential responsibilities and tasks:Manage the Drug Establishment License filing and updating process for Celopharma Inc.Provide QA Support in the creation, review of change controls; complaint and deviation processing; APQR reviews; Drug Product Batch ReleasesPerform batch record review of incoming imported drug productsRequesting GMP documents from Corporate QA team and/or fabricators to comply with GUI0001Liaison with local warehouse regarding the proper storage of drug product; inspection and retention of samples; returns/destruction; and other quality requirements regarding the drug productsWrite QA SOPs as requiredSupport Celopharma QA in regulatory authority inspectionsEvaluation of fabricator Product Quality reportsSummarize Canadian data to complete local Annual Product Review ReportsPreparation of Quality Distribution AgreementsLiaise with Business Partners to address non-conformances (ie. product complaints) within their respective territoryQualifications, experience and skills required:Knowledge and training requirements:Work experience requirements:Minimum 2 years experience with quality assurance work experience in a pharmaceutical organizationExpected professional skills:Capable of managing tight project timelines when required. Works well with minimal supervisionPossess good judgement and decision-making skillsMaintains professionalism at all timesExcellent communication skills (verbal and written)Willingness to continue to educate self on new technologies; policies; guidelines and implement the best practicesPossesses the educational and technical skills required for the positionIs adaptable; flexible and creative. Have a great work ethicCapable of dissecting complex situations and problem-solve #J-18808-Ljbffr

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