BAXTER
Location
Mississauga, ON | Canada
Job description
This is where you save and sustain lives
At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.
Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.
Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.
Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.
Your Role at Baxter:
To support the following major Quality Systems and ensure a state of compliance and continuous improvement:
Training/Documentation
NCR/CAPA
Change Control
Field Actions/Product Holds
Product Release
Annual Compliance (e.g. APQR Review, EBR Review, Stability Review)
Quality/Distribution Agreements
3PL Oversight
What you'll be doing:
Provide support for the following activities within the Quality department
Product Release including:
Review of laboratory documentation, transportation and warehouse receiving documentation
Disposition of imported and domestic product
Communicate and collaborate with 3PL on issues, deviations and corrective/preventative actions related to product distributed in Canada.
Communicate and collaborate with Quality Associates/Specialists/Sr. Specialists and manufacturing sites on issues, deviations and corrective/preventative actions related to product distributed in Canada.
Communicate and collaborate with laboratories to ensure product is tested and results are provided in a timely manner.
Communicate any issues that could impact product supply to Quality Operations partners.
Manage and maintain all quality documents.
Manage Quality Operations responsibilities associated with product compliance including but not limited to review and/or approval of compliance documentation such as APQR, Batch records, stability data, master manufacturing/packaging documentation.
Provide review and support of tasks related to launching of new products, as required.
Support review and approval of Quality/Distribution Agreements.
Management of the Global document implementation program (1QSYS) locally; ensuring all Global policies and procedures are adopted fully and in a timely manner
Optimization of the 1QSYS program
Support 3PL oversight activities
Providing Quality onboarding training sessions
Lead and/or participate in departmental process improvement initiatives
Administrative BAXU training system support
Run Training reports, scorecards, and manage training dashboards
Simplify and optimize Training transcripts at Head Office
Development and maintenance of Head Office training plans
Provide support , as required, to ensure products are launched in a timely manner.
What you'll have:
University Degree and/or applicable post-secondary education and experience/ Major in Sciences/Health Sciences/Pharmacy
3-5 years in a related industry
General knowledge of Quality systems (NCR/CAPA, Change Control, Documentation, Training, Product Release, Review of annual compliance documentation such as APQRs, initiate and implement Quality/Distribution Agreements in a GMP environment
SOP/Technical Writing experience
Experience in training plan development and conducting training
Working in IT systems
Experience working with a 3PL
Excellent knowledge of GMPs and Health Canada regulations for drug products, biologics and medical devices
Prior Quality Assurance experience in the Pharmaceutical or Medical Device Industry
Drug and/or medical device product release/product disposition experience
Strong communication and Technical Writing skills
Strong ability to take initiative
Good interpersonal/influencing/negotiation skills
Self-motivated, self-directed and enthusiastic
Good Project Management skills and ability to multi-task across many areas or projects
Computer skills in MS Office (Word, Excel, Windows, Access) and Windows operating system
Ability to grow and develop relationships with internal partners
Nice to have:
University Degree in Sciences/Health Sciences with additional post-graduate training and certification in Quality Control/Quality Assurance / Chemistry, Biology, Engineering / Pharmaceutical Quality Assurance
5-7 years in a related industry
Quality Operations in a GMP environment
Experience reviewing master and executed manufacturing/packaging documentation
Prior experience reviewing and approving compliance documentation
Previous experience with Corporate and/or MoH audits
Experience with laboratory methods and method transfers
Strong understanding of Health Canada GMP & Medical Device Regulations
Project Management experience
Internet web creation/maintenance
Excellent project management
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.Recruitment Fraud Notice
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