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View Cache (Job ID 13858546)
Employer Hrm
Job Title Senior R&D QA Executive
Description

Our client is a global innovator organisation with core competencies in the fields of pharma, biotech, medical devices and diagnostics to name but a few. Employing upwards of 30,000 people worldwide, this organisation sets trends in research-intensive areas with their products and services designed to benefit people and improve their quality of life.


The Role:
Our client currently requires a strong Senior R&D Quality Assurance Executive to join the Quality team on site in Galway. You will report to the Senior QA Manager and ensure that R&D operations, product transfers and quality processes are followed in a compliant manner.

Key Responsibilities:

  • Maintain efficient document management systems ensuring high quality of documentation within the R&D Department.
  • Ensure R&D operations, laboratory activities, stability program and product transfers are conducted in compliance with global policies, procedures and applicable regulations.
  • Conduct conformity assessment audits of R&D policies, procedures and quality systems to identify non-conformities and ensure prompt and effective correction actions are accomplished, ensuring the R&D department are in a state of continuous audit readiness.
  • Function as Quality System SME for R&D related CAPA's, Deviations, Non-conformances, Vendor non-conformances and Change Control, responsible for prompt and efficient closeout. Monitor and report KPI Quality metrics of the R&D department for the site.
  • Mentor, support and assist in the development of junior members of staff.
  • Maintain a strong relationship with site manufacturing activities and support the approval of registration batches to support regulatory submissions.

The Person:

  • Minimum of a Bachelor's degree (or equivalent) in a Science related discipline and 6 years' relevant experience within a pharmaceutical/medical device company with a minimum of 4 years' experience within a QA role.
  • Knowledge of working within an FDA/HPRA regulated facility.
  • Knowledge of product development processes desirable.

To learn more apply online or contact Orla Boyle at HRM directly on 353 91 782110 for a confidential chat.



This job originally appeared on RecruitIreland.com
Location Galway
Date Added 18 days ago
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