Computer System Validation Specialist II
Computer System Validation Specialist II
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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 onglobal CSV matters. Provide specialized knowledge and information which is directly needed to supportcompliance of all computer and computerized systems with relevant regulatory. Responsibilities includeparticipating as a project team member on computer system implementation projects both locally andregionally to assure that validation activities and life cycle methodology are incorporated and documentedappropriately during and after the project in accordance with company standards and procedures. Key andcritical responsibility will be to represent IT and Quality in discussing CSV strategy and work performed toregulatory 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/Pharmaceuticsand 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
auditors.
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 processimprovements.
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.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
