Description
A Global pharmaceutical company is seeking a QA officer to join there team for a six month contract in there brand new plant in North Dublin.As a member of the Quality function the successful candidate will
- Develop and implement site Quality Systems to support the manufacture and release of Combination products, including SOPs, document control, change control, investigations, CAPA, internal auditing, Vendor qualification & management, material and batch disposition, complaints and annual product review
- Collaborate with manufacturing and engineering functions to drive quality awareness, facilitate Good Manufacturing Practices and implement improvements to ensure product quality.
- Conduct checks and reviews of manufacturing operations to monitor factors which may affect product quality.
- Review and evaluate all executed manufacturing batch records to facilitate disposition of intermediate product and final product for Batch release.
- Review and participate in deviations and change controls to ensure appropriate investigation and assessment is carried out and actions implemented and monitored.
- Ensure compliance with appropriate regulatory guidance documents and local procedure
- Comply with company and Legislative Environment, Health and Safety Requirements.
- Support and execute any other duties as assigned
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The ideal candidate will have a desire to be involved in an exciting start-up and will be looking to further their career. - Educated to degree level (Life Sciences or Chemistry) with 3+ years industry experience.
- Working knowledge of US FDA, 21 CFR part 210 and 211 and EU GMP requirements
- Experience in or knowledge of inhalation dosage forms an advantage.
- High proficiency in Microsoft Word/Excel/Powerpoint/MS Project etc.
- Proficiency in electronic systems/databases such as documentation, Trackwise, SAP etc.
- Good team working and strong communication skills across functions and organization.
- An ability to work flexibly in a changing environment. Good attention to detail and priority management essential.
- The ability to work under pressure to demanding schedules is important, as is the ability to work on one's own initiative
If you are interested in this great opportunity and have the relevant skill set and experience please contact me Anna Mooney or apply below with an up to date CV.