Alliston, Ontario

Computer System Validation Specialist

Title: Computer System Validation Specialist
89 Centre Street South
New Tecumseth, ON,
Canada L9R 1J4
Remote Possible?: No

Job Description: 

(State the overall objective of the job in one or two sentences) 
• Support execution of the Validation Master Plan and Change Control associated with Data Integrity and Computer Systems Validations for the Alliston facility. 
• Prepare, execute and document data integrity computer system validation protocols in accordance with local and Corporate Quality Policies/Procedures, Health Canada Regulations, FDA 21 CFR Part 11, GMP, GUI 50 (Annex 11) and PI 041-1 for data integrity. 
• Manage the installation and qualification of new and existing equipment and instruments with a focus on computerized systems , working with a diverse team to achieve maximum results in minimum time. 
• Other tasks as assigned 

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. 

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. 

Time Spent Major Responsibilities / Activities 
80% • Prepare and execute validation protocols (IQ/OQ/PQ) for: Computerizd Systems related to production automated equipment, utilities and facility systems, in accordance with appropriate regulatory agency validation requirements, Baxter procedures, and current industry best practices 
• Coordinate validation and IQ/OQ/PQ activities site wide and coordinate with outside contractors providing leadership, training and guidance. 
• Monitor and support the execution of the protocols through training, facilitating and problem solving activities 
• Perform Impact Analysis for changes related to automated production equipment, computerized system, Utilities and Facility Systems 
• Compile required data and perform data analysis as required per validation protocols 
• Investigate and troubleshoot problems and determine solutions 
• Prepare validation reports and ensure all Validation activities are conducted in compliance with GMP, company procedures and policies, safety standards and applicable SOPs 
• Report and record any open issue from procedures or other discrepancies that may affect or indicate a problem with product quality. Determine and implement any immediate corrective action as necessary and ensure the development and implementation of long-term corrective actions by identifying root cause and facilitating the final implementation of the corrective actions 
• Support initiation, action, and closure of Change Control, NCR and CAPAs, as required 
• Perform retrospective validation packages as required for legacy systems and processes. 
• Prepare or assist in the preparation of Validation Maintenance (periodic review ) packages. 
15% • 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. 
5% • Complete requested month end validation 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. 
• Other tasks as assigned. 

JOB REQUIREMENTS (Preferred may be specific to the business unit) 

Education Level 
• Bachelor of Science or IT/Computer Science or Bachelor of Applied Science/Engineering (Computer Software/Systems) 

• Graduate Degree in Computer Science/IT/Engineering (Computer Software/Systems) 
Major Subjects / Specialties 
• Science (Information Technology, Computer Science, Engineering) 
• N/A 
Type of Experience 
• Computerized System/Software Validation experience 
• Manufacturing & Quality background 
• Previous experience in a GMP environment 
• Knowledge of Canadian GMP, GAMP5, 21 CFR Part 11, and Regulatory standards 
• Knowledge of Corporate Quality requirements including Data Integrity 
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. 
• 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 
• Understanding of LEAN enterprise through the application of LEAN tools. 
• Proficiency in Trackwise System 
• ASQ Certification 

(Describe typical decisions made in this job; indicating difficult decisions and challenges encountered) 

• Assessing validation requirements prior to generating any protocols or documents. 
• Identifying any out of limit or unexpected validation results, working with a team of individuals to investigate and resolve (may include working with other Validation Specialists) 
• Must interpret GMPs, Corporate Quality Standards and regulations to determine Baxter’s position regarding validations and method transfer. 
• Establish and setting high standards of quality while operating in a business environment which requires risk taking, flexibility and strong decision making. 
• Assessing the impact of current changes on systems. 
• Must interpret regulations and standards based on good quality practices and good business requirements. 
• Must be able to build good relationships with internal and external customers. 
• Maintaining technical expertise and product knowledge to support good decision making. 
• Maintaining quality and patient safety first while recognizing the importance of good business decisions. 
• Must be able to coach other areas in data integrity / computerized system processes.

Within 30 years, ALTEN has become leader in R&D, Engineering, Information Technology Services, Life Sciences and Network Services with 37,000 consultants working in more than 20 countries.

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