Hobson Prior are looking for a QA Validation to join a fantastic biotech organisation on a permanent basis located in Shannon. Our client is focused on developing solutions that might possibly be a cure for those who suffer from serious illnesses.
Please note that to be considered for this role you must have the right to work in this location.
- For this role, you will offer oversight on project-connected deviations.
- Uphold comprehension of cGMP, Good Engineering Practices and direction connected to all aspects of validation across manufacturing, laboratories and facilities.
- Accountable for guaranteeing that any GMP documentation allocated are to be closed in a RFT state and timely manner, such as issues, CAPAs, change controls, BMRs & audit/inspection actions.
- The ideal candidate will prepare and uphold the Irish site validation plan for the business.
- Discuss and/or offer training within the necessary validation standard to both personnel and contractors.
- Evaluate and approve validation, qualification protocols and reports.
- Responsible for upholding and filing validation/qualification documentation.
- You will interface with any other divisions, for example: Engineering, QC Laboratories, Operations, Supply Chain and Process Development to guarantee that validation project plans are both comprehended and adhered to.
- Any other assigned duties.
- Educated to a degree level in a scientific/engineering field.
- Fluency in the English language.
- A background in quality assurance within a pharmaceutical or biotech production setting in sterile manufacturing.
- Familiarity offering QA technical assistance as well as oversight to validation and qualification actions and with executing the ideas, legislations, regulations and needs linked to qualification and validation of sterile products, aseptic procedures, equipment and systems, which involves computer systems validation, such as Computer System Validation, for example: EU/FDA GMP guidelines, EU Annex 15, PIC/S & GAMP guidelines, EU Annex 11 & CFR Part 11 and ICH Q9.
- Expertise on cell culture-based manufacturing practices, needs, cellular and gene therapies.
- Prior involvement using risk assessment tools which involves FMEA.
- Capable of balancing requirements of the business with the requirements of the regulatory challenges.
- Works well in an ambitious, deadline-driven setting.
- Able to manage various tasks concurrently.
If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
€40000 - €50000 per annum
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