Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
This position is located in Vaughan, Ontario
This position is responsible for managing the release of import, domestic or third party products (as per assigned portfolio) at the warehouse in accordance with all applicable Regulatory, Certified Body and Quality System requirements. This position also has the responsibility of performing associated Quality compliance activities such as ensuring compliance documentation is reviewed and kept up to date for imported drug products.
Essential Duties and Responsibilities
- Manage the Quality responsibilities associated with product release as per assigned porfolio, including but not limited to:
- Over labeling process (if applicable)
- Sampling and Testing
- Submission Documentation Review
- Documentation Review
- Product release
- Compliance Certificates
- Product Storage and Sample Retention
- Submission of release documentation to regulatory body
- Product Release in JDE and GWS
- Liaise with Regulatory Affairs (RA) and Manufacturing sites for the timely receipt of product compliance files, CPIDs, batch records, stability studies, APQR summaries, master production documents, MRA certificates and other Quality System documents.
- Review, approve and compile annual compliance files.
- Complete month end compliance progress summary reports for Management Review
- Initiate process and product deviations per applicable quality system.
- Investigate and implement mitigation actions as necessary.
- Provide product disposition based on available stability data when applicable.
- Manage closure of applicable deviation in the timeframe required per applicable quality system.
- Direct the global teams on Canadian Quality requirements for new domestic and import products prior to product submission to Health Canada and/or receipt of product in Canada; actively participate as the Canadian Quality representative.
- Manage other special projects as required, ensuring all Quality related tasks are completed in conformance with business and regulatory requirements.
- Evaluate product returns, and provide required product disposition based on available data.
- Manage and maintain organization (Filing) of all quality documents for the warehouse.
- Evaluate the effectiveness of Quality Standard Operating Procedures and Supplier Agreements and update as required.
- Complete all training requirements.
- Manage and maintain organization of all Quality documents in the warehouse. Update SOPs and Supplier agreements as required. Prepare and/or update monthly metrics report for Management Review.
- Identify and implements Process improvements
Education and Experience
• Bachelor of Science or Engineering
• Bachelor of Science or Engineering with additional Post-graduate training and certification in Quality and Regulatory Affairs
Major Subjects / Specialties
• Chemistry, Biology,
• Chemistry, Biology, Engineering
Type of Experience
• Prior QA experience in the HealthCare or Pharmaceutical Industry
• Excellent knowledge of GMPs, and Health Canada regulations for drug products, biologics and medical devices
• Manufacturing experience/QA Operations in a GMP Environment
Years of Experience
• 3 years
• 5 years
Additional Skills / Special Training / Technical Skills Required
• Ability to build strong relationships with internal and external customers
• Detail oriented with the ability to work under pressure
• Excellent communication
• Time management skills, able to manage multiple projects and priorities
• Decision making skills, dealing with ambiguous situations and customer focus
A Career That Matters
Baxter's employees are united in a mission to save and sustain lives. We are passionate about applying scientific innovation to meet the needs of the millions of people worldwide who depend on our medically necessary therapies and technologies. We focus on increasing access to healthcare, innovating in crucial areas of unmet need, and pursuing creative collaborations that bring our mission to life for patients every day.