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Orla Crowley

Orla brings more than nine years of specialist recruitment experience and a background of more than 15 years working in healthcare to her role in Wallace Myers International.

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Quality Systems Specialist

Permanent
Mayo
€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.

Job 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.

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

At Wallace Myers International Recruitment Agency we specialise in sourcing professionals for key industries and services. See our website for more details.

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This position was pPosted on 31 May 2021

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