Senior QA Compliance, Quality Systems
Job Title: Senior QA Compliance, Quality Systems
Location: Meath, Ireland
Contract Type: Initial 11-month contract role
The purpose of this role is to work within and support the Global Development Quality Assurance team at the BioNX Research & Development Division facility in Dunboyne. This role will primarily provide support for SAP Quality Master Data build, Master Data approvals hypercare, sustainment, and ongoing updates.
Key Responsibilities:
* Lead SAP master data build and data approval activities including hypercare, sustainment materials build, BOMs and Recipes.
* Participate daily on cross-functional teams collaboratively and actively to address compliance issues and achieve project milestones.
* Support implementation and training for site Quality Systems and ensures activities are in Compliance with the current Quality Manual Requirements
* Support completion of Quality Systems activities e.g. related to Documentation Management, Auditing, Deviation Management, Change Control, Supplier Management and Quality Risk Management, per schedule
* Create and maintain assigned SOPs.
* Provide QA review and approval of Change Controls, Deviations/CAPAs, SOPS and related documentation for compliance to GMP and site requirements at the start-up facility.
* Support site QA Operations and QA Validation colleagues, as required.
Requirements:
* Bachelors degree, or higher, in a Life Science discipline
* 2-3 years experience in an FDA / EMA regulated environment, ideally in Quality Assurance, Quality Control or Technical Operations within the Biological and/or pharmaceutical industry.
* Previous experience in QMS development and maintenance.
* Strong written and verbal communication skills.
* Ability to think logically and be proactive under pressure.
Estimated Salary:
$60,000 - $80,000 per annum, depending on experience.