Job Reference: JO-2207-66272_1658222930
Our client has a unique opportunity for a QA Specialist to join the team in a large Pharmaceutical 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!
- Reviews routine manufacturing and engineering documentation including batch manufacturing records
- 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
- Participates in site Strategic, Technical and Operational Excellence projects on behalf of QA and represents the QA function at relevant cross-functional meetings
- 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)
- Basic knowledge of OPEX Lean tools, and root cause analysis tools used for identifying and correcting deviations.
- 4+ years of relevant experience in a GMP environment related field and a BS.
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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