Engineering & Electronics
QA Specialist required to join an expanding team in Cork to help support the Quality Operations unit.
- 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 JSCI by 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
Education and Experience:
- Bachelors Degree in a scientific/technical discipline required
- A minimum of 5 years experience in a quality or compliance role within the biological and/or pharmaceutical industry.
- 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.
- Advanced degree (MS, MBA, PhD) preferred
- Experience in C&Q, and Process validation
- Experience in direct interactions with regulatory agencies during site inspections.
Interested candidates should submit an updated CV.
Please click the link below to apply, call William Cunnage on +353 21 4297900 or alternatively send an up to date CV to William.email@example.com
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***