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QA Specialist

Quality & Laboratory
Claire Goulding
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Job Reference: JO-2209-66304_1663252262


Our client has a unique opportunity for a QA Associate to join the Quality Operations Unit in a large Biotechnology company. If you are someone who wants to be part of an organisation that brings life-changing medicines to those who need them, this could be the career step for you!


· 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.


· A 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.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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