Clinical Quality Specialist / Auditor (m/w/x)
Reviewing veterinary clinical studies and conducting GxP audits for animal health products. Master's degree and QA auditing experience in pharmaceutical sector required. 30 days leave, bonus plan, flexible working.
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Anforderungen
- Master’s degree or higher in Life Sciences
- Early experience in regulated GxP environment
- QA auditing knowledge
- Proven quality assurance experience in pharmaceutical sector
- GCP and GMP environments experience
- In-depth knowledge of regulatory requirements
- Knowledge of industry standards for veterinary medicinal product development
- Strong compliance skills in regulated environment
- Strong documentation skills in regulated environment
- Proven risk management expertise
- Successful track record implementing risk mitigation strategies
- Excellent interpersonal skills
- Excellent communication skills
- Effective collaboration across diverse teams
- Strong relationship building with stakeholders and leadership
- Proficiency in digital tools for document management
- Proficiency in digital tools for quality assurance processes
- Innovative problem-solving abilities
- Critical thinking abilities
- Ability to work independently
- Exceptional self-organisation skills
- Exceptional planning skills
- Good written communication skills in German
- Good verbal communication skills in German
- Good written communication skills in English
- Good verbal communication skills in English
Aufgaben
- Review veterinary clinical studies for compliance
- Conduct internal and external audits per GxP guidelines
- Support qualification activities in line with GMP
- Review qualification documentation for accuracy
- Apply risk management to identify and mitigate risks
- Assist in maintaining the GxP quality system
- Assist in improving the GxP quality system
- Manage Standard Operating Procedures (SOPs)
- Manage training related to GxP
- Collaborate effectively within a team
- Work in an intercultural environment
- Work in an interdisciplinary environment
- Demonstrate a proactive work ethic
- Demonstrate an independent work ethic
- Organize and plan tasks efficiently
- Meet deadlines for tasks
Berufserfahrung
Ausbildung
Sprachen
Tools & Technologien
Benefits
- Competitive salary
- Bonus plan subject to company annual results
- 30 days of leave
- Solid Pension Plan
- Flexible working arrangements
- Hybrid working model
Von Nejo automatisch aufbereitet
Nejo hat diesen Job automatisch von der Website des Unternehmens Merck & Co., Inc., Rahway, NJ, USA erfasst und die Informationen auf Nejo mit Hilfe von KI für dich aufbereitet. Trotz sorgfältiger Analyse können einzelne Informationen unvollständig oder ungenau sein. Bitte prüfe immer alle Angaben in der Originalanzeige! Inhalte und Urheberrechte der Originalanzeige liegen beim ausschreibenden Unternehmen.
Zur Originalanzeige bei Merck & Co., Inc., Rahway, NJ, USAÜber das Unternehmen
Merck & Co., Inc. is a global biopharmaceutical company committed to discovering, developing, manufacturing, and marketing a broad range of innovative health care products.
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