- For one of our international clients in the pharmaceutical industry we are currently looking for a
Environmental monitoring and qualification specialist (m/f)
- Responsible for achieving compliance with requirements including mitigation of determined gaps.
- “hands dirty” approach: executes all work required to achieve compliance, including authoring of all relevant documents (protocols, reports, SOPS, etc), and training.
- Serves as the subject matter expert for the sterile topic applying advanced theory, technical principles and expert judgment.
- Support the team and team lead in achieving the team compliance objectives.
- Ensures that the compliance approach and associated documentation is endorsed.
- At least 5 years’ experience in Human Health sterile manufacturing and/or sterile compliance.
- Experience in FDA regulated environment.
- Subject Matter Expert in the sterile topic.
- Proven ability to author GMP documentation right first time.
- Excellent teamwork skills.
- Excellent communication and training skills
- Project experience and ability to work independently (self-starter)
- Ability to operate in a global environment with a high level of diversity and different cultures.
- Fluent in German and English language.