Description
QA officer required to join a pharmaceutical company in Dublin for a 12 month contract initially. Supporting the Quality function the QA Specialist will be involved in an exciting start-up in the Dublin area.Role:
* 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
* Assist Manufacturing, Supply Chain and Engineering in the development and implementation of department systems and procedures
* Provide QA support to site start-up activities by performing document reviews and audit readiness verification checks.
* 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
Requirements:
* Educated to degree level (Life Sciences or Chemistry) with 5+ years industry experience.
* Working knowledge of US FDA, 21 CFR part 210 and 211 and EU GMP requirements
* Experience in designing and implementing quality systems and/or a start-up
* 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 organisation.
* 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 this is you please apply today.