Posted on :
21 Jan, 2014
21 Jan, 2014
Specific Outcomes / Accountability
Collaborate with other IT members, Quality Officer and business functions on systems validation efforts and the improvement of existing IT Quality processes/practices
Apply risk based approach principles to author and review validation documents supporting GxP computerized systems and relevant infrastructure
Provide oversight of computer validation projects to assure compliance with company policies, standard operating procedures and regulatory requirements
Oversee the execution of testing in support of change control to computerized systems including SOPs, scripts and reports
Work with regional teams to ensure global validation strategy is understood and followed
Provide IT business integrator expertise for systems supporting the Quality processes
Requirements:
Key Attributes
Qualifications & Experience
Must have pharmaceutical industry experience
3+ years of quality management experience in validation of computerized systems of varying complexity
Knowledgeable with computerized systems regulations of the US and EU (21 CFR Part 11 & Validation)
Good understanding of life cycle development and implementation processes
Familiar with risk based approach concepts and application to validation strategies and activities
Bachelor’s degree or certification in computer science or information systems related area with computerized systems and validation or equivalent experience
Salary: Market Related
Type: Permanent
AA Position: No
Work Level: Middle Management
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