QA Officer

Republic of Ireland  ‐ Onsite
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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.
Start date
n.a
From
Quanta Consultancy Services
Published at
07.06.2014
Contact person:
Lee Mitchell
Project ID:
723179
Contract type
Freelance
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