IT Validation Analyst Job Vacancy

Posted on :

21 Jan, 2014

Category :

Analyst Jobs in South Africa

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

  • Ability to multitask effectively
  • Quality orientation
  • Attention to detail
  • Process driven
  • Proactive
  • Self starter
  • Initiative
  • Add value

 

 

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

 

Click here to apply online

Work Level: Middle Management

 


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