{"id":16382,"date":"2014-01-21T11:57:09","date_gmt":"2014-01-21T09:57:09","guid":{"rendered":"https:\/\/joblistsouthafrica.com\/?p=16382"},"modified":"2014-01-21T03:01:52","modified_gmt":"2014-01-21T01:01:52","slug":"validation-analyst-job-vacancy","status":"publish","type":"post","link":"https:\/\/joblistsouthafrica.com\/validation-analyst-job-vacancy.html","title":{"rendered":"IT Validation Analyst Job Vacancy"},"content":{"rendered":"
Specific Outcomes \/ Accountability<\/strong><\/p>\n Collaborate with other IT members, Quality Officer and business functions on systems validation efforts and the improvement of existing IT Quality processes\/practices<\/p>\n Apply risk based approach principles to author and review validation documents supporting GxP computerized systems and relevant infrastructure<\/p>\n Provide oversight of computer validation projects to assure compliance with company policies, standard operating procedures and regulatory requirements<\/p>\n Oversee the execution of testing in support of change control to computerized systems including SOPs, scripts and reports<\/p>\n Work with regional teams to ensure global validation strategy is understood and followed<\/p>\n Provide IT business integrator expertise for systems supporting the Quality processes<\/p>\n Requirements:<\/strong><\/p>\n Key Attributes<\/p>\n <\/p>\n <\/p>\n Qualifications & Experience<\/strong><\/p>\n Must have pharmaceutical industry experience<\/p>\n 3+ years of quality management experience in validation of computerized systems of varying complexity<\/p>\n Knowledgeable with computerized systems regulations of the US and EU (21 CFR Part 11 & Validation)<\/p>\n Good understanding of life cycle development and implementation processes<\/p>\n Familiar with risk based approach concepts and application to validation strategies and activities<\/p>\n Bachelor\u2019s degree or certification in computer science or information systems related area with computerized systems and validation or equivalent experience<\/p>\n <\/p>\n Salary: Market Related <\/p>\n\n
\nType: Permanent
\nAA Position: No<\/p>\n