Senior Specialist, QA Computer System Validation

Job Summary

Primary QA approver in the local and global CSV Program. Contributes to the development and maintenance of the Computer System Validation (CSV) Program. Responsible to ensure all validation activities are performed as laid out in company governing policies and procedures.

Job Responsibilities

• As part of member of the cross-functional CSV team ensures validation activities are performed accurately and in a timely manner, using sound, technical judgement in making decisions and recommendations while managing workload and prioritizing in line with department and company objectives.
• Recommends and reviews changes to validation program, quality systems, and approved procedures. Ensure information, processes, directives, etc. are accurate, practical, and compliant to Apotex, Regulatory and Industry standards.
• Schedules and conducts team meetings Provides routine updates to management on validation progress, including timely escalation of issues with a potential impact on validation study intent/outcome.
• Leads Computer System Validation projects and provides the necessary guidance to other site personnel to ensure satisfactory and timely completion of all validation activities.
• Authors or reviews/approves procedures, risk assessments and documentation related to computerized systems to ensure that company and industry quality standards and compliance expectations are met.
• Liaises between departments for the creation, review, and approval of validation deliverables, operating procedures, and quality systems.
• Co-ordinates, schedules and performs the review and approval of validation/qualification documents and change controls.
• Provides technical expertise/assessment, reviews and approves deviations, observations and change controls to ensure that the computer system is maintained in an accurate, validated and compliant state over the lifecycle.
• Participates in vendor, regulatory, Self Inspection and Customer Audits as a subject matter expert in the Computerized System Validation program.
• Participate and provide input to the electronic data governance program.
• Review and approve computer system periodic reviews to ensure the system is in validated state and makes recommendations for re-validation, where required.
• Identifies training needs, develops modules and delivers training to site personnel
• Acts as project lead or provides support/guidance to assigned compliance and/or efficiency projects.
• Provides backup support in process, equipment and cleaning validation programs; participates in the review of validation related documents and acts as designated back-up to other members of the QA Validation group, including Management in delegated areas of responsibility.
• Works in a safe manner collaborating as a team member to achieve all outcomes.
• Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
• Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
• All other relevant duties as assigned.

Job Requirements

• Education

• Education at the University, or equivalent, level in a related scientific discipline.

• Knowledge, Skills and Abilities
  • Good working knowledge of applicable regulatory guidelines including FDA (21 CFR Part 11), ICH, and GAMP.
  • Practical background and superior understanding of validation principles and regulatory requirements/guidelines (Canada, USA, GAMP, EU, PIC/S and ICH).
  • Understanding of API / Pharma and/or related industries validation environment.
  • Strong verbal communication and technical writing skills; good negotiation, training and presentation skills would be an asset.
  • Effective project management and leadership skills.
  • Proficiency in computer applications and programs such as Word, Excel, PowerPoint and Project Management related software.
• Experience

• Minimum ten years’ experience in the Pharmaceutical Industry in the area of Validation, with focus on Computerized Systems.  Knowledge in analytical method validation, equipment qualification, process and cleaning validation is desirable.