Job Title: Quality Assurance and Validation Engineer
We are seeking a skilled Quality Assurance and Validation Engineer with the following expected skills:
1. Extensive knowledge and experience in Quality Systems and Operational Quality, including Deviation Management, Change Control, Laboratory Investigations, and Environmental Monitoring.
2. Proficiency in Batch Disposition preparation, Batch Record review, and Certification process oversight.
3. Strong understanding of cGMP and regulatory requirements.
4. Experience with Trackwise or similar Quality Management Systems.
5. Ability to support all quality and compliance requirements for commercial manufacturing.
6. Capability to use knowledge to improve Quality Systems and Operational Quality, solve complex problems, and support continuous improvement initiatives.
7. Understanding and application of regulatory and compliance requirements, ensuring alignment with current or upcoming changes.
8. Skill in interpreting client needs, assessing requirements, and providing solutions to non-standard requests.
9. Commitment to maintaining the highest standards of Quality, Compliance, and Safety.
10. Ability to work collaboratively with clients, ensuring alignment and the adoption of best practices in Quality Systems and Operational Quality topics.
11. Excellent oral and written communication skills in English.
12. Willingness to travel throughout Italy, with some European travel expected.
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