Lead Quality, Compliance and Computer Software Validation (CSV) activities in relation to software used in business systems, laboratory & manufacturing equipment, product development and products.
Responsibilities:
- Continue to meet the requirements of relevant regulations and are fit for purpose.
- Collaborate with project teams to determine the validation strategy and plan for execution.
- Quality reviewer on CSV and system supporting documentation.
- Lead Quality and Compliance activities in relation to Software projects.
- Author computer system validation documentation; test scripts, protocols, reports.
- Pre and post execution approval for all validation test scripts.
- Computer Software Validation within the medical device industry
- Experience of implementation and validation software business systems is desired.
- Understanding of ISO 13485 and FDA QSR quality standards, particularly 21 CFR
- Familiarity with GAMP5 Guideline for ‘Risk Based approach to GxP Compliant Computerised systems.
