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Quality Specialist, Document Management ( Contract )

Company: Baxter International
Location: Ontario
Posted on: January 12, 2021

Job Description:

Are you looking for a career that matters?We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We---re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.Learn more about how Baxter is At the Intersection of Saving and Sustaining Lives.SUMMARY OF RESPONSIBILITIES The person in this role is responsible for handling the administration of GMP documents centrally for the Alliston site, including procedures and records related to manufacturing and testing. The person in this role is considered the Process Owner for Document Management Life-cycle which includes document creation, design, review, revision, approval, obsoletion and retention. He/she ensures the Document Management Life-cycle Process is compliant to Baxter QMS requirements and Health Canada requirements. He/ she must (1) conduct appropriate review and approval of GMP documents (2) own execution and changes of site Document Management Lifecycle Process procedures to ensure they incorporate cGMP expectations being aligned to Baxter Global Processes/ Procedures as well as Health Canada (3) identify CA/PAs to prevent issues from happening again, (4) escalate significant quality issues related to Document Management to the Quality Systems Manager and Quality Management Representative (QMR) in a timely fashion.ESSENTIAL DUTIES AND RESPONSIBILITIES Own site Documentation Management procedures. Conduct changes, as needed, to ensure they incorporate cGMP expectations, being aligned to Baxter Global Processes/ Procedures as well as Health Canada expectations.Manage the Document Change Control System.Drive execution of periodic review on procedures with Process Owners to ensure that procedures are aligned to Baxter QMS and Health Canada expectations.Coach procedure (e.g., SOP) owners to identify opportunities to reduce complexity, ensuring there are records from key steps/ instructions and helping design documents that are easy to follow while compliant to expectations.Partner with Training personnel to confirm Training Target audience for families of SOPs and other procedures needing training to ensure procedures can be made Effective after Issuance.Plan, handle and conduct regular meeting with stakeholders to discuss the best strategies to improve the company---s quality procedures and practices.Partner with Documentation Technician to ensure tasks are aligned to the Documentation Management priorities.Oversee consolidation of facility documentation and records.Drive actions to ensure document archival conditions and retention requirements are met, while ensuring easy retrieval of documentation.Promptly notify and escalate potential/ emerging significant quality/compliance issues related to Documentation Management to the Quality Systems Manager and QMR.Manage all GMP Documentation data analysis activities and drive compilation of information in support of Management Review Meetings and other site forums. Ensure the data is accurate and complete, with data shared on a timely basis and actions identified that are commensurate to the risk.Support Inspection Readiness activities.Liaise with functional areas such as Operational Quality and Manufacturing-Engineering-Warehouse to drive improvement actions regarding manual and electronic procedures and forms.Remains current with respect to regulatory trends and divisional issues.Partners with facilities, divisions, and regions to ensure successful implementation and compliance to Global Quality Processes/ Procedures/regulations.JOB REQUIREMENTS University Degree, Bachelor of Science, Pharmacy or Engineering. Science (Chemistry, Microbiology, Pharmacy, Engineering).Knowledge and experience applying current GMPs, ISO and regulatory standards (Health Canada, FDA).Experience in a Pharmaceutical Manufacturing environment.Good written and communication skills.Strong analytical skills, problem solving skills and critical thinking abilities.Risk Management knowledge (e.g., ICH Q9: Quality Risk Management).Experience applying Risk Management principles.Ability to identify interfaces between elements that should be connected (e.g., Complaints and Nonconformances).Attention to detail.Strong ability to balance multiple priorities.Knowledge of Statistical Process Control and basic statistics.Experience with foundational Quality System elements, including Documentation Management, Training, Change Control, Nonconformance and CAPA.Experience with Health Canada inspections.Knowledge of Six Sigma and Lean tools/ principles.Experience with Electronic Batch Record (EBR).Experience with Documentation Management software.Regulatory Affairs Graduate Certificate.Years of Experience Required: 5 - 8 years of experience Ability to work with multi-functional teams.Willing to learn. Learning agility.Intermediate to Advanced proficiency in Word, Excel, PowerPoint.Proficiency in Trackwise System.Experience with Electronic Batch Record (EBR).Assessing the impact of issues that may arise as part of significant Documentation Management gaps (retrospectively, to other systems/ processes/ products).Determining need to interact and/or request support from Subject Matter Experts within the site or global groups as necessary to share and confirm issues that may arise.Escalation to management as necessary.Must keep abreast of evolving cGMP expectations.Must be able to build good relationships with internal and external stakeholders.Maintaining technical expertise and product knowledge to support appropriate decision making.Maintaining quality, compliance and patient safety first mentality while recognizing the importance of business requirements/ conditions.Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTAbaxter.com and let us know the nature of your request along with your contact information.Job InfoType: Full timeLocation: Alliston, Ontario

Keywords: Baxter International, Ontario , Quality Specialist, Document Management ( Contract ), Executive , Ontario, California

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