Site QA + QSS - Quality Standards and Systems Specialist

Posted 10 March 2023
SalaryCompetitive Rates
LocationWicklow
Job type Permanent
DisciplineLife Sciences & Engineering Technologies
ReferenceBBBH29569_1678447334
ContactDeanna Healy

Job description

A leading global pharmaceutical company dedicated to supporting customers and their businesses in ever better ways, this organisation delivers quality medicines and vaccines, complemented by diagnostic products, genetic tests, bio-devices, and a range of services. Selling in over 100+ countries with over 10,000 employees, this organisation is one of the largest health-care organisations in it's defined sector. They are currently looking for a Site Quality Assurance Specialist (QSS) to join their operation.

The Position

  • As a Site Quality Assurance Specialist (specialising in QSS, Quality Systems and Standards) you will report into the Site QSS Lead.

  • You will be responsible for QMS Oversight and Management, Supplier Qualification and Management, Site Auditing Programme and Regulatory submissions.

  • Other duties include Analytical Method Transfer and Validation Approvals as well as site Data Integrity Oversight.

  • You will serve as administrator for site Quality Systems; Document Management, ETS, LMS and Quality Master Data Approver for SAP and ZLIMS, and independent system administrator for Laboratory and Operations IT Systems as required.

  • Evaluation, approval and monitoring of suppliers including Quality Agreements (end to end supplier approval and management).

  • As part of the remit as QA Specialist / QSS, you may be required to perform tasks such as Batch Release on a case-by-case basis where needed, and once trained to do so.

The Person

  • You will be degree qualified in science (pharmaceutical, biological, or chemical science).

  • The ideal candidate will have 3-5 years' experience in Quality within Pharma, Biopharma, or GMP environment.

  • Useful to have; Trackwise, SAP, and Veeva Vault experience.

  • Experience in Supplier Management / Auditing, Validation or Regulatory Affairs is essential.

  • This is a great time to join this organisation as they are on a journey of change with great growth opportunities here.

To discover more about this opportunity, apply now or contact Déanna Healy at HRM on +353 87 636 9263 for a confidential discussion.