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CareerZone Limited

Quality Engineer

CareerZone Limited

  • Offaly / Westmeath / Galway
  • Negotiable
  • Permanent full-time
  • Updated 07/10/2017
  • Aiden
this job is expired
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Description

My client a major Global Pharmaceutical company are hiring a Quality Specialist within the QA Department reporting to Associate Director QA.

 

DESCRIPTION

My client a major Global Pharmaceutical company are hiring a Quality Specialist within the QA Department reporting to Associate Director QA.

 

KEY RESPONSIBILITIES

 

  • Function as Quality Technical Lead with special responsibility for projects relating to computerised system and process automation control systems.
  • Function as Quality Technical Lead on projects relating to facility, utility and equipment changes/upgrades in line with strategic objectives.
  • Serve as Quality Technical lead for qualification/validation based activities to support the above in line with current guidance and site/global procedures 
  • Participate in and support risk management activities in line with relevant guidance and best industry practice.
  • Provide input and guidance to deviation management activities resulting in appropriate root cause analysis and relevant CAPA actions
  • Provide leadership, guidance and support to data integrity initiatives and systems.
  • Evaluate new and prospective Regulatory guidance and industry best practice and determine impact on current Quality systems, identifying and implementing appropriate updates where required.
  • Build collaborative relationships within and across the business to ensure critical path deliverables are achieved.
  • Challenge practices and procedures in current area of expertise, offering new ideas and/or solutions to enhance performance within the function/site
  • Work proactively as part of a team and provide constructive input into resolution of problems impacting on Quality and the project.
  • Participate and/or lead internal and external audits in order to maintain existing Quality standards and facilitate continuous improvements.
  • Participate in compiling and maintaining departmental KPIs.
  • Ensure adherence with best health and safety practices.

 

REQUIREMENTS

  • A third level qualification in science, engineering, information technology or suitably related field is required.
  • 8 years’ experience in the pharmaceutical or related industry preferably in a Quality or Validation related role is desirable..
  • Previous experience in CSV or related area is essential
  • Knowledge and understanding of data integrity requirements
  • In-depth understanding of industry standards and best practices for computerised systems validation e.g. GAMP 5,
  • In-depth knowledge and understanding of cGMP regulations and guidelines including but not limited to 21 CFR Part 11, Eudralex Vol. 4 Annex 11, ICH Q9, Q10
  • Excellent organisational, communication and interpersonal skills.
  • Excellent report writing skills and attention to detail and accuracy.
  • Proven track record in your current role is essential.
  • Flexibility to move within QA groups as the business requires.

Ref: QE21Ca
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CareerZone Limited

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