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Ruth Holland
Life Science

01 507 9255
[email protected]
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Details

Senior QA Specialist


Reference:/RH/AJUY-071551 Location: Dublin
Dublin City Centre
Qualification:DegreeExperience:4-5 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: QA Specialist

We’re currently recruiting for an exciting QA Contract opportunity with Biotechnology start up project based in Dublin.This position will focus on QA support in a few projects that are ongoing at the moment. Requirements will revolve around QMS activities e.g. change controls and completion of change actions, Quality agreements, SOP writing, preparation of documentation required to support regulatory submissions etc, CAPA tracking and close out.


The Position
Reporting to the Senior Director International Quality this position is responsible for supporting quality activities as part of the client's global expansion initiative. This is a hands on position requiring completion of actions to support the rapid expansion of the companies global footprint and new product launches intetnationally.

Responsibilities


  • Responsible for coordinating the collation of documentation suporting dossier submission in various markets.
  • Responsible for supporting the implementation of Quality Techincal Agreements with partners.
  • Responsible for setting up partners/vendors in the electronic quaity management system and ensuring all supporting documentation is in place for vendor approvals.
  • Responsible for supporting the qualification and ongoing oversight of partners internationally through collation of evidence to close audit CAPAs.
  • Resposnible for tracking metrics & QMS records to ensre timely completion of actions in accordance with established procedures and timelines.
  • Responsible to support in inspection readiness activities for global partners and support regulatory inspections as necessary.
  • Assist in annual Quality Management Review and monthly QMS review activities.
  • Support self inspection program where applicable.
  • Support in the qualification of customers and GDP QA activities as required for example shipping vlaidation, deviations, complaints, temperature excursions.
Qualification and Experince:
  • Must possess knowledge and experience in a GxPs regulated industry in multiple geographies
  • 5+ years of experience in pharmaceutical Quality, preferably Quality Systems
  • BA/BS, preferably in science
  • · Strong understanding and background in Quality Management Systems.
  • · Previous experience creating and presenting metrics on Quality Management Systems.
  • · Experience with VEEVA QualityDocs highly preferable but not essential
  • Self-motivated and good interpersonal skills with proven ability to communicate, both verbally and in writing, to all levels of the organization
  • Must be capable of handling multiple tasks and prioritizing work in a fast paced dynamic work environment
  • Ability to deal with ambiguity and a high rate of change
  • Excellent written and verbal communication skills
  • Demonstrated organizational and project management skills
  • Strong computer skills (e.g. Microsoft applications such as Word, Excel, PowerPoint, etc.) with proven skills for generating reports, presentations and statistics




Any applicant must have an existing valid work permit/ visa to apply. (Stamp 4 or EU passport).

Contact ruth.holland @lifescience.ieor 087 7822 198 for more details.