Operations Quality Systems Specialist

My client, a global CRO company based in Mayo, is recruiting for an Operations Quality Systems Specialist. This is a full time permanent position.

Main Duties & Responsibilities:

• Responsible for the processing of all Analytical Services Department Quality Documents, i.e. Deviations, LIRs, Facility replies, audit responses, change controls, etc.
• Tracking and applying corrective/preventive actions and checking effectiveness of same.
• Assessing the impact of changes to facilities/systems/equipment and processing of change control documents.
• Liaise with the Quality Assurance Department to process quality documents.
• Generate new and update current standard operating procedures if required by CAPA
• Assist with the implementation of systems to improve Quality and raise Quality awareness among staff in the Analytical Services Department. 
• Review of data.
• Dealing with internal and external customers as required.
• Involvement with regulatory and client audits as required.

PERSON SPEC:

The successful candidate must have:

• Scientific/Quality Systems qualification.
• 2--4 years’ experience of working in a Medical Device/Pharmaceutical/CRO industry i.e. GMP/Quality experience.
• GMP background essential.  Comprehensive understanding of GMP compliance and how it relates to the quality system.
• IT skills – MS Word, Excel, Powerpoint etc.

• Technical knowledge of Analytical testing is essential, with particular focus on HPLC/UPLC systems and knowledge of Empower 3

For a full Job Spec and to apply for this role please call Zoe on +353 1 2784671 or e-mail zhamilton@thornshaw.com

Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671