Aseptic Manufacturing Specialist
2 weeks ago
The ideal candidate will serve as the primary point of contact and decision-maker during New Product Introductions, Technology Transfer, and Process Validation activities for aseptic products. Responsibilities include:
- Reviewing and approving Process Development and Validation documentation, technical transfer documents, and Validation Protocols.
- Executing validation documents and reports, while providing quality direction and input at Change Control and Deviation Review Boards.
- Ensuring compliance with company safety standards and SOPs throughout all activities.
Key qualifications for this role include:
- University degree in a science or engineering-related discipline (preferable).
- Relevant experience (7+ years) working in the pharmaceutical or biotechnology industry as a Subject Matter Expert, providing overall quality direction and oversight for key functional areas.
- Understanding of principles of Validation and New Product Introduction.
- Experience in aseptic manufacturing, change control, non-conformance, corrective, and preventative actions, and validation practices.
Critical thinking skills, strong organizational abilities, effective communication and coordination skills, and meeting facilitation skills are essential. Independent and self-motivated individuals who can multitask in project environments and excel in collaboration are ideal candidates.
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Dublin, Dublin City, Ireland Grifols, S.A Full timeSelect how often (in days) to receive an alert: Create AlertWould you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in...
