- Supports GMP activities from operational through to Laboratory support programs.
- Partners with other Departments to ensure that compliance programs are completed in an efficient manner and are effectively maintained.
- Responsible for implementation of systems and procedures for the management of change control and deviation management, as it applies to plant installations, systems, and operations in accordance with GMP.
- Quality oversight of project activities including but not limited to, C&Q activities and process validation through to commercial manufacture.
- Participates as a key quality member in inspections and audits of external parties/agencies.
- Key participant within the QA team in the execution of their duties.
- Executes the activities of the group within quality to create a synergistic approach to goals and tasks.
- Domestic and international travel may be required.
- Bachelor's Degree in a scientific/technical discipline required
- Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
- Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.
- Focus on patients and customers at all times.
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The Life Science Specialists