I'm looking for...
close

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

crome
Google Chrome
IE
Internet Explorer
firefox
Mozilla Firefox
opera
Opera

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Contact Info
Libby O'Donoghue
Life Science

+353 1 507 9254
[email protected]
Connect with me on
Risk Manager
Dublin
Process Engineer
Limerick
VP of R&D
Galway
Regulatory Affairs Specialist
Republic of Ireland
Quality Engineer
Limerick
Apply for this job

Name:

Surname:

Email:

Phone:

Cv:

Salary Expectations:

Education:

Experience:

Current Location:

Notice Period:

Write here your cover note:


If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to [email protected]
Details

Quality Operations Senior Specialist (LOA008170)


Reference:A008170 Location: Dublin
Qualification:DegreeExperience:4-5 Years
Job Type:Temporary ContractSalary: Not Disclosed
May be suitable for: QA Specialist

The Role
This Pharmaceutical company is looking to recruit aQuality Operations Senior Specialist, Drug Product, EMEA and Asia Pacificon a 12 month fixed-term contract (maternity cover)to provide quality and compliance oversight support to the Quality Operations management team within External Manufacturing.

Key Duties and Responsibilities:

  • Support the coordination of quality events, change control and market complaints programs in respect of Third Party Manufacturer and Alliance Partnership relationships.
  • Actively support the Fact Finding (FF) and Product Review Committee (PRC) processes for major investigations involving Third Party products.
  • Provide quality/compliance support to the wider Supplier Relationship Management, Global Procurement, Supply Chain and MT teams in support of new projects, technical transfers programs, supplier selection programs, investigations, validation programs etc.
  • Provide the requisite quality support to Global functional groups such as Global Regulatory/CMC and the local country based regulatory managers in support of regulatory filings, product renewals, regulatory agency questions etc.
  • Coordinate quality metrics programs in relation to Third Party performance.
  • Provide support to Quality Operations Management Team in Technical Transfer projects and Manufacturing Launch Teams (MLTs) relating to Third Parties.
  • Assist in the preparation of Quality Agreements with the Third Party Manufacturers and Alliance Partners.
  • Review the Annual Product Reviews submitted by the Third Party Manufacturers.
  • Support the Global external auditing program by participation in audits of Third Parties as requested.
  • Provide support to specified quality and technical projects as they arise.

Qualifications,Knowledge and Skills Required:

  • In depth knowledge of cGMP regulations pertinent to the USA, EU and other international markets
  • Ability to develop cross-functional and external working relationships
  • Strong communication and presentation skills across all levels both internal and external.
  • Proven analytical and problem solving skills.
  • A BSc in a scientific discipline such as Chemistry or Microbiology
  • Minimum 5 years’ experience in the pharmaceutical industry, preferably in Quality, Manufacturing Technology, Regulatory or a position within a Health Authority Agency
  • Experience and technical knowledge in chemical, biological and/or pharmaceutical operations which enables firsthand knowledge of manufacturing, quality control, quality assurance, regulatory affairs/sciences and interface with research & development
  • Ideally will have experience in interacting with Health Authorities and supporting Health Authority inspections
  • Direct experience in interfacing with external manufacturers


Why you should apply

  • You will help patients in their fight against serious diseases
  • You willbe part ofa company that encourages excellence and innovation, respects diversity, develops leaders and values its employees.
  • You’ll get a competitive salary and a great benefits package