Quality Specialist, Document Management ( Contract )
Company: Baxter International
Location: Ontario
Posted on: January 12, 2021
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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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