Computer System Validation Specialist
Title: Computer System Validation Specialist
89 Centre Street South
New Tecumseth, ON,
Canada L9R 1J4
Remote Possible?: No
SUMMARY OF RESPONSIBILITIES
(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.
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.
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)
• 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)
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.