Job Title: Senior QA Specialist - Compliance and Quality Systems
This is an exciting opportunity to join a leading multinational pharmaceutical organization based in Meath.
About the Role:
The successful candidate will provide support for SAP Quality Master Data build, Master Data approvals hypercare, sustainment, and ongoing updates. They will also be responsible for supporting the interface of SAP with IPI Product structure and MES BOMs and recipes.
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 ensure 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.
* Support creation, maintenance and continuous improvement of Quality Management Systems (QMS) and associated documentation.
* 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.
* Work collaboratively to foster strong relationships with management and colleagues and to drive a safe and compliant culture.
* Support gathering of site metrics.
* Ensure the escalation of compliance risks to management in a timely manner.
Requirements:
* Degree qualification (Science/Quality/Technical).
* 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, QRM, SQM, Deviations and Change Control, participating in investigations and problem solving.
* Previous experience in quality management systems such as Veeva, SAP, Delta-V, TrackWise, PAS-X etc. or similar.
Salary: €60,000 - €80,000 per annum.