QA Executive – Galway | Collins McNicholas

QA Executive – Galway

  • Reference: GY44892
  • Job Type: Permanent
  • Location: Galway
  • Category: Science, Pharmaceutical & Food

Reporting to the Senior Manager Quality Operations Injectable, the Quality Assurance Executive position will support complaints/escalations/FARs investigations, PQR review and batch records review of products manufactured/ packaged by my client’s Affiliate Injectable sites.

Responsibilities:

  • Investigation of product complaints of affiliate sites & associated vendors and of third parties.
  • Support the affiliate sites in investigations related to escalations (such as but not limited to OOT / OOS laboratory investigations, process deviations).
  • When applicable, file FAR in timely manner and investigate the reported defect.
  • Review of Product Quality Review (PQR) Reports for affiliate injectable sites.
  • Preparation and review of SOPs
  • Preparation of monthly/quarterly/annual KPI/Management review data as required.
  • Provide training to QA Regional staff & QA Affiliate staff at the relevant manufacturing & packaging site in GMP practices and procedures.
  • Liaise with Clinical, Manufacturing and Packaging sites as required.
  • Support other activities of the Regional Quality team such as but not limited to :
    • Batch records review
    • Deviations review
    • Product technical files
    • Continuous improvement tasks / projects
    • Preparation and control of Technical Agreements and Confidentiality Agreements.
    • Support Annual Reports submission, Product Development and Product Launch for Injectable Affiliate Sites.
    • Support Affiliates Injectable sites inspections if required
    • Provide technical transfer and process validation support. Review equipment, process, method validation protocols and reports.
    • Review of stability data, stability protocols, stability reports for affiliate Injectable sites
  • Perform other duties as assigned.

Skills, Experience and Qualifications:

  • Minimum of a Bachelor’s degree (or equivalent) in a life science or pharmacy and 3-5 years of experience in quality control or quality assurance within a pharmaceutical/ medical device company.
  • Experience of sterile injectable manufacturing and third party/affiliate site quality management desirable but not essential.
  • Experience with QC/Manufacturing Deviations

  • Experience with Regulatory Bodies
  • Quality QA and/or QC experience working in a pharmaceutical GMP environment.
  • Experience in QA operational and compliance issues – investigations, complaints, batch review, deviations etc.
  • QC experience is an advantage in OOT / OOS / analytical investigations.
  • A knowledge of Trackwise software is an advantage.
  • As this role supports affiliate injectable sites, an experience in third party manufacturing oversight and/or sterile manufacture is ideally required.

For a confidential discussion and more information on the role/company please  email your CV to: amy.oneill@collinsmcnicholas.ie


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Amy O’Neill

Contact Consultant

  • Amy O’Neill
  • Recruitment Consultant
  • 091706718
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