Site QSS - Contract
- Posted 28 November 2024
- SalaryUp to €60000 per annum + FTC or Contract
- LocationWicklow
- Job type Contract
- DisciplineLife Sciences & Engineering Technologies, Science Leaders & Specialists
- ReferenceBBBH30570_1732797429
- 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, biodevices, and a range of services. Selling in over 100+ countries with over 10,000 employees, this organisation is one of the largest healthcare organisations in its defined sector. They are currently looking for a Quality Systems Specialist to join their operation, on a 12-month contract basis.
The Position
As the QSS, you will cover a 12-month term. Our client is open to both FTC and contractor solutions for this position.
Your responsibilities will include:
QMS oversight and management.
Supplier qualification and management.
Involvement in site auditing programme.
Supporting regulatory submissions.
Approvals for Analytical method Transfer and Validation.
Data Integrity oversight.
Working in Partnership with System and Sub System Owners to Design, deploy and maintain compliant, robust, aligned, lean and efficient quality systems and tools at the site to support GMS and commercial strategy and the product lifecycle.
Oversee the site data integrity program and act as system administrator for key Quality Systems e.g. Trackwise (ETS), Document Management System (Veeva Vault), Learning Management System (LMS), Quality Master Data in SAP & ZLIMS and systems where the system administrator is required to be independent from the user function Empower 3, other Lab and Operational computerised systems.
Responsible for site Quality system governance and metrics and leading management reviews to ensure QSS consistently remain in place and complies with the organisation's Global Quality Policies.
The Person
Seeking candidates with minimum of BA Degree in Science.
5 years relevant experience in Pharmaceutical or Biopharmaceutical.
Experience with supplier management, auditing, validation or Reg Affairs.
Recognised LSS qualification (yellow, green, black belts desirable).
To discover more about this opportunity, apply now or contact Déanna Healy at HRM at +353 87 636 9263 for a confidential discussion.