Validation Expert QA - Ludenscheid, Deutschland - Clearstone GmbH

Clearstone GmbH

Geprüftes Unternehmen

Ludenscheid, Deutschland

vor 2 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

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 problemsolving skills, with a keen sense of prioritization
Collaborative team player with excellent communication abilities and a structured approach to tasks.