Validation Expert QA

My client is a global leader in the pharmaceutical industry. For their Global Business Services Division (GBS), they're currently looking for a:
**Validation Expert - Quality Management**

Embark on an enriching journey with our company, where you'll gain comprehensive insights into the GBS Enabling Services Organization, focusing primarily on Validation Management tasks and responsibilities. As part of a dynamic global team, you'll be immersed in designing, constructing, and enhancing our clients' worldwide processes, leveraging agile principles, methodologies, and tools.

In your role as a Validation Specialist within Quality Management, you'll be empowered to contribute effectively to cross-functional teams. Your responsibilities will include coordinating change requests, conducting impact analyses, reviewing and endorsing documents, and ensuring the continuous validation of systems.

**Key Tasks & Responsibilities**:

- Enforce validation protocols in collaboration with local experts within our GBS user community to manage changes effectively
- Maintain compliance and validate the state of our processes and systems consistently
- Oversee and document testing activities meticulously
- Demonstrate proficiency in Agile methodologies and tools, actively engaging in projects governed by this approach
- Familiarity with project environments and performance measurement against KPIs/SLAs, driving continuous improvement initiatives
- Fluent in English, with substantial experience in pharmaceutical or biopharmaceutical production or related fields such as quality assurance
- Bachelor's Degree, preferably in engineering, sciences, pharmaceuticals, or biotechnology, coupled with extensive professional experience in regulatory frameworks and processes
- A comprehensive grasp of pharmaceutical regulations, encompassing FDA, ICH, and European Pharmacopoeia standards
- Desirable theoretical knowledge of Computer Systems Validation (CSV) regulations, including GAMP5, 21 CFR Part 11, CSA framework, EU Annex 11, and Data Integrity regulations
- Experience with Agile methodologies (e.g., SCRUM, Kanban) and associated tools (e.g., JIRA) would be advantageous
- Strong analytical aptitude and problem-solving skills, with a keen sense of prioritization
- Collaborative team player with excellent communication abilities and a structured approach to tasks.