Computer Validation SpecialistReq # JR - 023653 Location Alliston, Ontario, Canada Job Category Quality Control Date posted 08/05/2020
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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.
The top two priorities for all Baxter Alliston employees are Safety and Quality:
Safety: Support our goal to achieve a “Zero Harm Environment”, by ensuring the safety of yourself and your co-workers through:
- following all safety procedures
- understanding potential hazards in your area
- wearing appropriate PPE
- reporting all incidents / near-misses / concerns
- embracing 6s
Quality: Ensure the quality of our products to ensure patient safety and achieve our mission of “Saving and Sustaining Lives”. This can be achieved through:
- +++following Good Manufacturing Practices (GMP) +++
- adhering to all quality procedures
- completing training on-time
- Doing it Right the First Time, and
- reporting any quality concerns immediately.
As part of the plant’s Enterprise Management System (EMS), all employees must embrace a culture of Continuous Improvement by:
- participating in improvement activities
- identifying and implementing continuous improvement ideas
- participating in Tier meetings
- recognizing your peers, and
- embracing 6s.
- identifying and implementing VIP’s (Value Improvement Project)
- embrace continuous learning
- utilize Leader Standard Work
- utilize Root Cause Analysis tools to identify and prevent problems from recurring and drive measurable results.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Detail the major responsibilities/activities of the job in 3 to 6 statements.
Record responsibilities in order of most to least time spent. Record % of time spent in left margin.
Major Responsibilities / Activities
- Design IQ/OQ/PQ and validation campaigns as well as develop, prepare and write the protocols for equipment/software validation
- Coordinate validation and IQ/OQ/PQ activities among Quality Control Laboratories and outside contractors providing leadership, training and guidance.
- Monitor and support the execution of the protocols through training, facilitating and problem solving activities
- Perform retrospective validation packages as required for legacy systems and processes.
- Prepare or assist in the preparation of Validation Maintenance packages.
- Provides support for the Quality technical review/approval of department related procedural changes, and validations/protocols.
- Remains current with respect to regulatory trends and divisional issues related to their area of expertise.
- Partners with facilities, divisions, and regions to ensure knowledge sharing and successful implementation of Quality improvement initiatives.
- Completes requested month end summary/metric reports for Management Review meeting.
- Support the Baxter Quality System Improvement Plan (QSIP) by ensuring that activities outlined in related Baxter Quality Plans and protocols are completed, opportunities are identified and action plans created.
JOB REQUIREMENTS (Preferred may be specific to the business unit)
- Bachelor of Science or IT/Computer Science or Bachelor of Applied Science/Engineering (Computer Software/Systems)
Major Subjects / Specialties
- Science (Chemistry, Microbiology, Pharmacy, Engineering)
- Information Technology, Computer Science
Type of Experience
- Laboratory Equipment and Computer System/Software Validation experience
- Manufacturing & Quality background
- Previous experience in a GMP environment
- Knowledge of GMP, ISO and Regulatory standards
- Knowledge of Corporate Quality requirements
Years of Experience
- 2 – 3 years experience in a pharmaceutical environment
- 5+ years of successful experience in a pharmaceutical environment
Additional Skills / Special Training / Technical Skills Required
- .Strong understanding of Health Canada GMP and Medical Device Regulations.
- Thorough knowledge of applicable procedures, specifications, regulations and standards.
- Strong process and project management capabilities.
- Strong written and oral communication skills, negotiation skills, ability to work with all levels of the organization.
- Ability to build strong relationships with internal and external customers.
- Strong ability to balance multiple priorities.
- Role model personal accountability for results and integrity and relentless focus on rapid and disciplined action.
- Strong analytical and problem solving skills and critical thinking abilities.
- Intermediate to Advanced proficiency in Word, Excel, Powerpoint.
- Solid understanding of statistical tools/techniques
- PMP Courses or Certification
- Ability to support our transformation to a LEAN enterprise through the application of LEAN tools.
- Proficiency in Trackwise System
- Comprehension/Proficiency of Minitab
Baxter 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_TTA@baxter.com and let us know the nature of your request along with your contact information.