Work Schedule
Standard (Mon-Fri)Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job Description
Summary:
Support all Computer Systems Validation (CSV) activities at the Canadian sites as well as assisting on global CSV matters. Provide specialized knowledge and information, which is directly needed to support compliance of all computer and computerized systems with relevant regulatory. Responsibilities include participating as a project team member on computer system implementation projects, both locally and regionally, to assure that validation activities and life cycle methodology are incorporated and documented appropriately during and after the project in accordance with company standards and procedures. Key and critical responsibility will be to represent IT and Quality in discussing CSV strategy and work performed to regulatory and client auditors.
Essential Functions:
Support all Computer Systems Validation (CSV) activities at the Canadian sites as well as assisting on global CSV matters. Provide specialized knowledge and information, which is directly needed to support compliance of all computer and computerized systems with relevant regulatory. Responsibilities include participating as a project team member on computer system implementation projects, both locally and regionally, to assure that validation activities and life cycle methodology are incorporated and documented appropriately during and after the project in accordance with company standards and procedures. Key and critical responsibility will be to represent IT and Quality in discussing CSV strategy and work performed to regulatory and client auditors.
Essential Functions:
- Prepare and complete protocols and write reports.
- Prepare project-based documentation for computerized systems
- Attend project meetings.
- Provide support to Quality Operations/Business or Project management/ Operations/Pharmaceutics and Process Technology (PPT) as technical expert.
- Prepare protocols for non-computerized systems.
- Responsible for reviewing documents.
- Represent IT for client/regulatory/internal audits (GMP/SOX).
- Conduct periodic reviews on user access, audit trails and validated systems.
- Support IT and Quality in discussing CSV strategy and work performed to regulatory and client
- Generate, review and approve URS documents.
- Support and lead compliance of Deviation Reports (DRs) and Corrective Action Preventative Actions (CAPAs) for the validation department.
- Update Master Validation Plan (MVP) for Computerized Systems
- Maintain a continuous improvement attitude by actively participating in and initiating practical process improvements.
- Maintain a safe working environment and report potential hazards.
- Perform alternating and rotating shift work (as required)
REQUIRED QUALIFICATIONS
Education:
Post secondary diploma in Chemistry, Engineering, Science, or related field. BSc in Chemistry or Engineering is an asset.
Experience:
Minimum 3 years experience in Computer System Validation.
Minimum 3 years Information Technology expertise and experience with IT Infrastructure and IT
Application implementations.
Equivalency:
Equivalent combinations of education, training, and relevant work experience may be considered.