Quality Systems Specialist
€35000 - €45000 per annum
Operations Quality Systems Specialist
Our client a leading Pharmaceutical Company in Mayo are looking to a recruit experienced Operations Quality Systems Specialist to join their team. Performs technical laboratory activities in support of client studies or procedures. Performs analysis of data for quality and completeness and determines if results are as expected. Records data in compliance with company and regulatory policies and standards to meet quality and accuracy requirements.
- 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.
The Ideal Candidate
- 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.
- Meticulous attention to detail and high level of accuracy.
- Excellent problem-solving skills.
- Excellent interpersonal & communication skills, both written and verbal.
- Positive attitude
- Excellent report writing skills.
- Ability to work on own initiative as well as part of a team.
- Flexibility - Ability to work overtime as required.
- Technical knowledge of Analytical testing is essential, with particular focus on HPLC/UPLC systems and knowledge of Empower 3
For more information on the Operations Quality Systems Specialist role contact Orla Crowley on 0860286253
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This position was pPosted on 31 May 2021