QA Specialist position in QA Manufacturing & Facilities Support (12 months)
I am working with a leading Pharmaceutical organisation based in Cork that has a 12 month contract opportunity for an experienced QA Specialist. If you have Quality Assurance experience in a manufacturing environment this could be the role for you.
This role is a QA Specialist, contract role in the QA Department, under the QA Manufacturing and Facilities Support team. This specific role is required to perform QA review of manufacturing and engineering records & associated documents and QA review & approval of procedures and GMP deviations. This position requires a sound knowledge of quality assurance systems, methods and procedures. The candidate will be required to exercise judgment, within well-defined and established procedures and practices, to identify problems and appropriate actions and to generate alternatives and recommendations within defined processes. The candidate must be proactive in their daily activities and interactions.
Essential Duties and Job Functions:
* Assists in the completion of Manufacturing related customer complaint investigations
* Participates in authoring, reviewing and approving Standard Operating Procedures (SOPs)/other types of controlled documents
* Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions
* Review and approval of GMP Deviation investigations and CAPAs
* Performs internal audits and walkthroughs on behalf of the QA department to ensure site compliance to GMP
Knowledge, Experience and Skills:
* Prior experience in pharmaceutical industry is preferred (ideally within a QA role)
* Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems)
* Demonstrates working knowledge of quality assurance systems, methods and procedures.
* Basic knowledge of OPEX Lean tools, and root cause analysis tools used for identifying and correcting deviations.
Typical Education & Experience:
* 4+ years of relevant experience in a GMP environment related field and a BS.
* 2 + years of relevant experience and a MS.
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