QA Auditor GCP/GMP(m/w/x)

# QA Auditor GCP/GMP (m/w/d) **DEU - Rheinland-Pfalz - Schwabenheim** | **Full time** | **Hybrid** Job Description Join our enthusiastic R&D Quality Assurance team at Schwabenheim, where we uphold GLP, GCP, and GMP compliance in a dynamic global organization. Collaborating with multidisciplinary teams across Pharmaceuticals R&D and various service departments, you’ll work in alignment with both local and international regulations as well as our internal standards. This is a fantastic opportunity for a self-driven professional with a background in life sciences to not only advance their career but also actively shape the veterinary clinical QA profile and contribute to a streamlined and supportive QA infrastructure at our innovative research and development location. If you thrive in an international setting and seek personal development, we invite you to explore the exciting temporary role (until 31.12.2025) of a **QA Auditor GCP/GMP** (m/w/d) with us. We are seeking an experienced QA Auditor to support our R&D Quality Assurance and veterinary clinical R&D department in ensuring compliance with Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) regulations. The successful candidate will review clinical study and clinical trial material documentation, perform internal and external audits, and provide guidance in a GxP regulated environment. **Key responsibilities:** * Review veterinary clinical studies to ensure compliance with regulatory standards and internal processes. * Conduct internal and external audits in accordance with GxP guidelines to assess compliance and identify areas for improvement. * Support qualification activities in line with GMP requirements and review qualification documentation for accuracy and completeness. * Apply extensive knowledge and experience in risk management to identify, assess, and mitigate potential risks in processes. * Assist in maintaining and improving the GxP quality system to ensure ongoing compliance and operational excellence, including Standard Operating Procedures (SOPs) and training. * Collaborate effectively within a team, demonstrating strong communication skills and the ability to work in an intercultural and interdisciplinary environment. * Demonstrate a proactive and independent work ethic, with strong self-organisation and planning skills to manage tasks efficiently and meet deadlines. **Qualifications & competences:** * Master’s degree or higher in Life Sciences or a related field. * Minimum 3 years of experience in regulated GxP environment and QA auditing knowledge. * Proven experience in quality assurance within the pharmaceutical sector, particularly in GCP and GMP environments. * In-depth knowledge of regulatory requirements and industry standards for veterinary medicinal product development, complemented by strong compliance and documentation skills in a regulated environment. * Proven risk management expertise, with a successful track record in implementing effective risk mitigation strategies. * Excellent interpersonal and communication skills (in German and English), enabling effective collaboration across diverse teams and the establishment of strong relationships with key stakeholders and leadership. * Proficiency in digital tools and technologies for document management and quality assurance processes, alongside innovative problem-solving and critical thinking abilities. * Ability to work independently with exceptional self-organisation and planning skills to enhance quality assurance practices. **Benefits:** * Flexible working hours (37.5 hours/week) and an attractive company pension scheme * Competitive salary package: 13 monthly salaries + holiday pay + target bonus * 30 days holiday entitlement * Hybrid working model (up to 50 % remote) * Internal training and promotion opportunities * International co-operations * Training on the job * Contributing your own ideas to the process design * Insights into the development of veterinary medicinal products * Corporate benefits and free (electric) car parking * Good company canteen and a company health management program We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace. **Employee Status:** Project Temps (Fixed Term) **Relocation:** No relocation **VISA Sponsorship:** No **Travel Requirements:** 10% **Flexible Work Arrangements:** Hybrid **Shift:** Not Indicated **Valid Driving License:** No **Hazardous Material(s):** N/A **Required Skills:** Aseptic Manufacturing, Aseptic Manufacturing, Audits Compliance, Clinical Testing, Corrective and Preventive Action (CAPA), Detail-Oriented, Documentation Review, Document Management, Driving Continuous Improvement, GMP Compliance, Good Clinical Practice (GCP), Good Manufacturing Practices (GMP), Internal Auditing, Life Science, Management Process, Quality Assurance (QA), Quality Assurance Tools, Quality Auditing, Quality Management Systems (QMS), Quality Standards, Risk Management, Root Cause Analysis (RCA), Social Collaboration, Standard Operating Procedure (SOP), Supplier Quality Management {+ 3 more} **Preferred Skills:** **Job Posting End Date:** 06/13/2025 **\*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.**