Development and Automation Specialist
vor 3 Wochen
Transforming Possibilities into Reality
The role of a Development and Automation Specialist at AbbVie offers a unique opportunity to contribute to the development of innovative combination products. As a key member of our team, you will be responsible for aligning strategies with all CPD sites and stakeholders, ensuring compliance with regulatory requirements, and leading quality improvement initiatives.
Key Responsibilities
- Strategic Alignment: Collaborate with cross-functional teams to develop and implement quality strategies, including qualification, validation, and transfer.
- Regulatory Compliance: Ensure that equipment and combination products are designed in compliance with relevant regulatory requirements, including FDA, EMA, and ISO standards.
- Quality Improvement: Lead and guide quality improvement initiatives across all sites, developing a quality data integrity concept and supervising the execution of exploratory and verification testing.
Requirements
- Education and Experience: BS or equivalent education with 14+ years of experience, or MS or equivalent education with 12+ years of experience, or PhD with 6+ years of experience in a relevant scientific area.
- Skills and Knowledge: Significant experience with quality strategies, knowledge of ICH and ISO Guidelines, Good Manufacturing Practices (GMP), Design Controls, and FDA regulations.
- Software Tools: Experience with Electronic Lab Notebook (ELN) software and electronic DHF tools, such as Polarian.
About AbbVie
At AbbVie, we are committed to equality, equity, diversity, and inclusion. We believe that a diverse and inclusive workplace is essential to our success and the success of our employees. We offer a range of benefits, including an attractive salary, flexible work models, and comprehensive health and exercise programs.
Join Our Team
We are looking for talented individuals who share our values and are passionate about making a difference in the lives of patients. If you are a motivated and experienced professional, we encourage you to apply for this exciting opportunity.
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