Data Integrity Validation Engineer

Recruiter
PM Group
Location
Wiltshire
Posted
13 Apr 2018
Closes
20 Apr 2018
Sector
Engineering
Contract Type
Permanent
Hours
Full Time
PM Group requires a data integrity validation engineer to join the client validation team at a biopharmaceutical site in South West England. The successful candidate will undertake high-level QA activities on behalf of the client. The placement would be for an initial 8 months and is likely to extend.

The successful candidate will be engaged in the following main activities:
• Working as a seconded PM Group resource in a client-led team.
• Remediation of identified Data Integrity discrepancies following a GAP Analysis.
• Development of corrective actions.
• Ownership of discrepancies and corrective actions for both electronic and legacy paper records covering quality, engineering, labs and production.
• Generation of Validation Lifecycle Documentation.
• Generating/updating SOP’s, worksheets and logbooks.

Candidates must have proven experience of working in a similar role on multiple projects in the pharmaceutical/biopharmaceutical industry. Applicants must have good knowledge of existing regulations in the Pharmaceutical industry, specifically GAMP5, CFR21 part 11 - eRecord / eSignature, Data Management – Access & Security. Experience of QA activities and internal audits are essential

Similar jobs

Similar jobs