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QA Senior Associate - 4 cycle

Quality & Laboratory
Dublin
Claire Goulding
Contract
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Job Reference: JO-2209-66306_1663253031

Summary:

If you have a passion for all things Science, possess a strong desire for making positive differences to people's lives and want to be part of an organisation who put people first, then this might be the career change you are looking for? Our client, a leading biopharmaceutical is currently looking to appoint a QA Associate to serve as Quality point of contact for manufacturing operations.

Responsibilities

· Write, review and approve Standard Operating Procedures in accordance with Policies.

· Provide Quality support for triage and investigation of all classes of non-conformance (NC) events.

· Review and approval of deviations for closure ensuring compliance with appropriate documentation.

· Participates in customer complaint investigations.

· Provides training and advice to staff in order for them to perform their desired functions.

· Observe and provide real-time quality oversight, and support for production unit operations, extending to formulation, vial and Syringe Fill Finish related activities, including observation and provision of direction during media fills and assessment of aseptic interventions.

· Review/approve production batch records, and associated documentation in preparation for Qualified Person disposition activities.

Requirements:

· University degree. Engineering or Science related discipline preferred.

· Relevant experience (4 yrs +) working in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.

· Experience working with dynamic cross-functional teams and proven abilities in decision making.

· Strong organizational skills, including ability to follow assignments through to completion.

· Demonstrated ability in problem solving and experience in managing Root Cause Analysis /Deviation investigations.

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

Fastnet - The Talent Group
'Not Just Placers.........Partners'

The Life Science Specialists


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