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Quality Manager (GCP/GLP) (m/f/d)
ProtaGene CGT GmbH
Heidelberg, Baden-Württemberg
Qualitätssicherungen
GCP
GLP
SOPs
Biotechnologie
Pharma
ProtaGene is a world-leading CRO partner for the biopharmaceutical and cell and gene therapy industries. From research through product commercialization, we provide the most advanced, integrated, and complete protein and gene analytic capabilities and packages for biologic therapeutics as well as cell and gene therapy platforms. Our deep history of analytical leadership in protein-based therapeutics stems from the merger of Protagen Protein Services in Europe and BioAnalytix in the US. In 2021, GeneWerk’s unique capabilities in vector safety, integration site analysis, and bioinformatics were added to our portfolio, establishing ProtaGene. Our combined protein- and gene-based analytical platforms make it the leading analytic service provider across the biopharmaceutical and cell and gene therapy development spaces. The organization operates four sites in Europe and North America and works in advanced therapeutic platforms with leading biopharmaceutical and gene therapy companies worldwide.
For our Heidelberg location we are looking for the next possible date for a
Quality Manager (GCP/GLP) (m/f/d)
Your Responsibilities:
- Assisting in the expansion and maintenance of the Quality Management System, including future certification and accreditation responsibilities.
- Performing internal audits in accordance with GCLP, GCP and GLP guidelines.
- Participating in audits of external customers and regulatory agencies.
- Participating in qualification of equipment, systems, and suppliers.
- Organizing and overseeing employee training.
- Creating, revising, and reviewing documents such as SOPs and work instructions.
- CAPA, deviation, risk analysis and change control management.
- Active participation in quality assurance of ongoing laboratory and data analysis processes.
- Creation and review of qualification and validation documents.
Your Qualifications:
- Completed scientific studies in biology, biotechnology, medicine, pharmacy or comparable natural/biological sciences.
- Experience in quality assurance, preferably in the field of biotechnology or pharmacy.
- Knowledge of current international regulations for GCP/GLP direct experience would be an advantage.
- Experience with accreditation/certification procedures for GLP or in the DIN-EN-ISO field desirable.
- Experience with computer-based system validation and cloud-based IT systems is an advantage.
- Very good knowledge of written and spoken English is mandatory, very good knowledge of German an asset.
- Strong quality awareness and ability to apply quality knowledge in practical work.
- Integrity, commitment, and a motivated work ethic.
- Ability to work in a team and independently.
We offer:
- Responsible and varied tasks in a motivating working environment.
- A permanent position in a dynamically growing international life science group with over 200 employees.
- Optimal induction and training opportunities as well as individual development options.
- Appreciation, openness and respect as well as a lively feedback culture.
- Flat hierarchies, short decision-making processes and flexibility.
- Comprehensive health management.
- Job ticket.
- Job bike.
- Regular company and team events
We are looking forward to receiving your complete application documents in English or German. Please apply online.
ProtaGene | Europe
Attn. LUISA WASSERMANN
Executive Office & HR Manager
T: +49(0)6221/42790-0
Vollzeit
, Festanstellung
Fachkraft
Aktualisiert am
23.12.2024
Bitte beziehe dich bei deiner Bewerbung auf jobvector
Arbeitsort
Standort der Stelle
Im Neuenheimer Feld 582
69120 Heidelberg
Baden-Württemberg
Deutschland
Gut zu erreichen aus...
- Karlsruhe
- Mannheim
- Ludwigshafen am Rhein
- Darmstadt
- Worms
- Rüsselsheim am Main
Gehalt
Der angegebene Wert ist das geschätzte durchschnittliche Bruttojahresgehalt für vergleichbare Vollzeitpositionen.
€ 55.374
Über ProtaGene CGT GmbH
In the heart of the science and business location Heidelberg, GeneWerk GmbH has found ideal conditions for steady growth. For six years, the company with its experienced and motivated staff has been offering NGS-based molecular biological analysis services, especially for companies in the pharmaceutical, life sciences and biotechnology industries. The aim is to advance the development of...
Mehr über ProtaGene CGT GmbH