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QA Specialist

  1. Midlands (Ireland)
County Limerick
  1. Contract
Competitive
  1. CAPEX Projects
09-05-2024
34158
QA Specialist - Limerick, Ireland - 12-Month Contract 

Ireland is a hive of activity for the Life Sciences Sector at present with global players setting up new and expanding existing manufacturing facilities all over the Country. An exciting opportunity has arisen to work via Quanta on the client’s side for a global Pharmaceutical organisation on a major expansion project based in the picturesque Munster region of Ireland. 

Located just 20 minutes from the nearest international airport, the manufacturing site is workable for those wishing to commute to/from Ireland for a contract position. You will be required on site for 5 days per week Monday – Friday working 45 hours.


Role Summary:
  • Responsible for ensuring compliance with all aspects of Quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.
  • Maintains regulatory compliance in accordance with current Good Manufacturing
  • Practices (cGMP).
  • Collaborates with Cross functional teams to resolve issues, complete investigations and maintain compliance.
  • Responsible for review and approval of the following types of documents:
  • Failure investigations
  • Corrective and preventative actions (CAPA)
  • Standard operating procedures (SOP’s) 
  • GxP documents
  • Change control documents.
  • May lead & support root cause analysis ensuring appropriate CAPA are implemented to prevent recurrence where relevant as a quality approver. 
  • Reviews procedures, policies and other instructional documents relating to quality systems to ensure compliance with company policy and local and international regulatory requirements.

Requirements: 
  • Assoc Specialist - BS/BA in scientific discipline or related field or equivalent combination of education and experience
  • Specialist - BS/BA in scientific discipline or related field with 2+ years of relevant work experience in pharmaceutical or related industry or equivalent combination of education and experience
  • Sr Specialist - BS/BA in scientific discipline or related field with 5+ years or MS 4+ years of relevant work experience in pharmaceutical or related industry or equivalent combination of education and experience

If this role is of interest to you, please apply now! 


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