Site QA + QSS - Quality Standards and Systems Specialist
- Posted 08 March 2023
- Salary€58000 - €64000 per annum
- LocationWicklow
- Job type Permanent
- DisciplineLife Sciences & Engineering Technologies
- ReferenceBBBH29569_1678283378
- 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 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.
