A career is an ongoing journey of discovery: our 52,000 people are shaping how the world lives, works and plays through next generation advancements in healthcare, life science and performance materials. For 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
You will conduct audits to ensure that standards of quality are being met and such that risks are identified, escalated and can be mitigated. Furthermore, you’ll prepare audit reports and approve the CAPA of audits. You’ll contribute to audit findings trends and provide recommendation for improvement. The contribution to the internal and external audits plan based on assessment of risks as well as providing support and advice to the sites during audits will also be part of your role. You will maintain familiarity with current regulatory trends, analyze and provide recommendations on how the quality standards or systems should be modified and you’ll also identify best practices across the audited network and facilitate adoption across the quality network. The scope of your role includes internal development and manufacturing sites (pharma and biotech) as well suppliers, external laboratories and contract manufacturers. You’ll act as consultant to the sites for the implementation of harmonized compliant and pragmatic solutions and support HAs inspection preparation.
Who you are:
- Degree in a scientific or technical field with a minimum of 10 - 15 years’ experience in process, analytical, manufacturing or Quality at leading biopharmaceutical companies
- Certification by an accredited Quality organization is a plus
- Experience in auditing in an international environment with strong knowledge of GMP § GDP regulations, FDA 21 CFR, EU GMP as well as FDA and ICH Guidelines
- Strong knowledge of Data Integrity gaps and solutions
- Experience in Medical Devices environment, experience as Health Authorities inspector and knowledge of GCP a strong plus
- Strong observations and listening skills as well as communication and presentation skills (verbal and writing)
- Ability to interact with people at all levels: operators through CEO’s.
- Fluent in English
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
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