Senior QA Specialist - Compliance and Quality Systems
This is an exciting opportunity to join a leading multinational pharmaceutical organization based in Meath.
Role Overview:
The primary responsibility of this role is to provide support for SAP Quality Master Data build, Master Data approvals hypercare, sustainment, and ongoing updates. Additionally, the role will involve supporting the interface of SAP with IPI Product structure and MES BOMs and recipes.
Duties:
* 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.
* 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.
* Gather site metrics.
* Elevate compliance risks to management in a timely manner.
* Perform additional activities as assigned by the manager/supervisor.
Experience and Education:
* Bachelor's degree in Science, Quality or Technical field.
* 2-3 years' experience in an FDA/EMA regulated environment, preferably 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.
* Background in quality management systems such as Veeva, SAP, Delta-V, TrackWise, PAS-X etc.