Senior QA Specialist - Compliance and Quality Systems (Hybrid)
RK22321
Contract – 11 months
Meath
We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Meath. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.
This role will primarily provide support for SAP Quality Master Data build, Master Data approvals hypercare, sustainment, and ongoing updates. It will also support interface of SAP with IPI Product structure and MES BOMs and recipes. Other activities to support Quality Systems and QA Operations will be required as per start up schedule
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 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
• 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.
• Additional activities as assigned by the manager/supervisor
Experience and Education:
• 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
If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.
