Aktuelle Jobs im Zusammenhang mit Validation Expert QA - Tuttlingen - Clearstone GmbH
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Senior Process Engineer
vor 2 Wochen
Tuttlingen, Baden-Württemberg, Deutschland Berchtold GmbH & Co. KG VollzeitAbout Berchtold GmbH & Co. KGBerchtold GmbH & Co. KG is a leading manufacturer of medical devices, and we are currently seeking a highly skilled Process Engineer to join our Advanced Operations team.Job SummaryWe are looking for a talented Process Engineer to support the development and implementation of innovative manufacturing processes for our medical...
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Senior Process Engineer
vor 2 Wochen
Tuttlingen, Baden-Württemberg, Deutschland Berchtold GmbH & Co. KG VollzeitAbout Berchtold GmbH & Co. KGBerchtold GmbH & Co. KG is a leading manufacturer of medical devices, and we are currently seeking a highly skilled Process Engineer to join our Advanced Operations team.Job SummaryWe are looking for a talented Process Engineer to support the development and implementation of innovative manufacturing processes for our medical...
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Senior Process Engineer
vor 3 Wochen
Tuttlingen, Baden-Württemberg, Deutschland Berchtold GmbH & Co. KG VollzeitAbout Berchtold GmbH & Co. KGBerchtold GmbH & Co. KG is a leading company in the production of medical devices, and we are currently seeking a highly skilled Process Engineer to join our Advanced Operations team.Job SummaryWe are looking for a talented Process Engineer to support the development of innovative medical devices. As a key member of our team, you...
Validation Expert QA
vor 3 Monaten
21-03-2024- VERTRAGSART- Permanent- BESCHÄFTIGUNGSART- Vollzeit- BRANCHE- Pharma & Health- FÄHIGKEITEN- Alle- BERUFSFELD- Engineering, Quality (Pharma & Biotech)- GEHALTSARTEN- Jährlich- GEHALT- Verhandelbar- JOB-ID- 33134**Stellenbeschreibung**:
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.
Recruiter
- Robbert Roos
