Quality , Science, Pharmaceutical & Food

Quality Specialist – Deviations – Dublin

  • Contract
  • Remote
  • Dublin North
  • 41925496

PE Global are currently recruiting for a Quality Deviations Specialist on behalf of our client based in Dublin:

Deviation Management Specialist – 11 Month initial contract

 

The Quality Deviations Specialist ensures adherence to Good Manufacturing and Documentation Practices, Quality Manual and local procedures.

Ensure that QA team objectives are effectively achieved, consistent with MSD’s requirements to ensure compliance, safety and reliable supply to our customers.

 

Primary Responsibilities:

  • Serve as support Quality SME for site deviation management system.
  • Support the review and approval of site deviation and investigations reports.
  • Ensure root causes have been identified and corrective action implemented and can demonstrate basic knowledge of six sigma, LEAN, and root cause analysis tools used for identifying and correcting deviations.
  • Day to day management of Deviation and CAPA metrics.
  • Support internal and external audit preparations regarding deviation management system.
  • Support the delivery of site deviation training.
  • Support global meetings and activities for site deviation management system.
  • Works directly with cross-functional departments to ensure that quality system requirements are met.
  • Performs other duties assigned by Quality Management.

 

Qualification and Experience:

  • Bachelor’s degree (or higher) in Engineering, Chemistry, Biology, or relevant discipline
  • 3 years experience in Quality Assurance, Technical Operations or Engineering within the Biopharma / Pharmaceutical industry.
  • Experience working in regulated environment with exposure in the regulations & guidances – GMP, CGMP, GAMP, 21 CFR Part 11.
  • Must have at least 3 years’ experience with deviation systems and investigations.
  • Must have experience of compiling and reporting QMS metrics.
  • Experience with SAP entreprise system.
  • Experience with new product introductions and/or process qualification/technology transfer.
  • Strong contemporary knowledge of relevant cGMPs, regulations and current industry trends relating to deviation investigations and CAPA identification.
  • Technical writing skills.
  • Lean Six-sigma and problem solving tools.

 

 

Interested candidates should submit an updated CV.

 

Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up to date CV to audrey.mccarthy@peglobal.net

 

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***

 

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