Senior Quality Specialist

  • Type: Permanent
  • Location: Limerick
  • Salary: Negotiable
  • Job Ref: SQS090118
  • Date Posted January 9, 2018

Our client, a leading pharmaceutical company based in Limerick currently has a great opportunity for a Senior Quality Specialist to join their growing team. This is a full-time, permanent position offering an excellent salary and benefits package.

Summary: Performs and leads activities in support of dispositioning product and/or raw materials while ensuring compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Standard Requirement Documents.

Essential Duties and Responsibilities

  • Represent Quality Assurance in support of complex and/or significant Deviations, Change Controls, CAPAs, etc., including active participation in investigation, evaluation, and problem resolution,
  • Represents the IOPS organization on behalf of QA with external partners to communicate IOPS QA policy and procedures; liaise with external partners and provide input on regulatory communications.
  • Train and/or mentor employees, including providing insights and education on processes and procedures, and conveying expectations of QA organization;
  • Provides consultation or advice in alignment with QA policies;
  • Perform activities associated with disposition of raw materials and product (e.g. manufacturing record review, receipt, inspection, document review, shipping, etc.). Activities may be on the floor or at a desk
  • Review, edit, or approve controlled documents
  • Review and approve investigations associated with raw materials, product, laboratory, or facilities.
  • Perform status labelling of raw materials and product

Education and Experience:

  • Requires BS/BA in scientific discipline or related field and minimum 5 year relevant experience.
  • Relevant experience may be substituted for education requirement.
  • Understanding of biologics manufacturing operations is preferred.
  • Ability to stand for periods of time when performing tasks on the floor.
  • Ability to work a varied schedule including off shift and weekends

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For more information on this position please call Rachael O’Rourke on 061336136, alternatively apply online and a member of the Harmonics team will be in touch

More Details

Fore more information on this position please call Rachael O’Rourke on 061336136 or alternatively apply online and a member of the Harmonics team will be in touch

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