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This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives. The Quality Specialist (12-month assignment) is responsible for supporting the major Quality Systems and ensure a state of compliance and continuous improvement with product release, annual compliance, field actions/product holds, training and change control.
Job Responsibility:
Review laboratory, transportation, and warehouse documentation to ensure product release
Disposition of both imported and domestic products
Work together with 3PL and internal teams on matters and steps related to product distribution in Canada
Manage and maintain all quality documents
Conduct impact assessments and complete tasks for change controls
Review and approve compliance documentation such as APQR, batch records, and stability data
Support method transfers and the launch of new products as required
Assist with product holds and quality assessments of returned products
Participate in internal audits and regulatory inspections to ensure compliance
Requirements:
University Degree or equivalent experience and/or relevant post-secondary education and experience
Drug and/or medical device product release/product disposition experience
Excellent knowledge of GMPs and Health Canada regulations
Strong communication and technical writing skills
Ability to take initiative and multitask across projects
Experience with third-party logistics and quality frameworks such as NCR/CAPA, Change Control, and Documentation
Skills in MS Office and Windows operating systems
Nice to have:
University Degree in Sciences/Health Sciences or equivalent experience, supplemented by further post-graduate education
Experience in Pharmaceutical Quality Assurance, Chemistry, Biology, or Engineering
Prior experience with Corporate and/or MoH audits
Strong understanding of Health Canada GMP & Medical Device Regulations
Project Management experience
Decision-making skills for ambiguous situations and customer focus