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.
