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Quality Engineer
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Galway
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Clare
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Details
Quality Assurance Specialist (Logistics)
| Reference: | RK1559 | Location: |
Dublin |
| Qualification: | Degree | Experience: | 3-4 Years |
| Job Type: | Fixed Term Contract | Salary: | Not Disclosed |
May be suitable for:
QA Specialist
Quality Assurance Specialist (hybrid)
RK1559
Contract 6 months
Dublin
We’re currently recruiting for an exciting opportunity with a leading global logistics organization supporting the pharmaceutical and life sciences sector in Dublin. This is an excellent role for anyone looking to join a world-class multinational known for its high standards and strong reputation in quality and compliance.
Duties:
- Manage the preventative maintenance schedule and liaising with contractors to arrange site visits, follow up on reports and ensure appropriate documentation is received and internal logs are maintained.
- Ensuring all appropriate qualifications are performed for activities undertaken under the WDA, e.g. temperature mapping, monitoring, validation, equipment validation, system validation, transport validation.
- Liaising with contractors to arrange validations and site visits, peer reviewing protocols and reports and ensuring appropriate documentation is received and internal logs are maintained.
- Ensuring that the warehouse/facility is successfully operated in keeping with GDP, including temperature management, and that any excursions/issues are addressed and reported on a timely basis (CAPA’s closed out correctly).
- Drafting change controls and risk assessments in line with current EU and HPRA guidelines to ensuring a comprehensive and effective Quality Risk Management/Change Control & CAPA procedures is in place
- Drafting and updating Quality Technical Agreements and supporting with the third-party supplier approval process
- Support with managing the daily interfaces with supply chain, customer services and facility management to ensure all
- medicinal product receipts and deliveries are made in keeping with GDP best practice and per SOPs.
- Ensure that all records are completed in real time and to a high standard in keeping with SOP’s/Quality Systems.
- Assist with updating operational work instructions and updating SOPs
- Assist the quality team in ensuring that initial and continuous training programmes are updated, implemented and maintained.
- Ensure that all relevant complaints are investigated in a timely manner. Ensure that such complaints are documented and followed up to ensure that all appropriate corrective actions are taken
Educational and Experience
- University degree in an Engineering or Science-related discipline (preferred).
- Over 2 years of relevant experience in the pharmaceutical or biotechnology industry with an understanding of Good Distributions Practices
- Experience with handling deviations, CAPAs, risk management, change control, validations, document authoring and control, temperature monitoring and temperature control
- Familiar with EU GDP Regulation (2013/C/343/01)
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
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Life Science Recruitment | Tel:+353 1 685 4848 | Fax: +353 (0)1 443 05 24 | Email: [email protected] | Copyright © 2021 Life Science Recruitment Ltd
This site uses cookies. More information on cookies can be found in our Privacy Policy | Terms of Use | Registered as a private limited company. No: 445328
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