22321-Senior QA Compliance & Quality Systems Specialist-Meath Contractor

This is an 11-month contract and is a hybrid position.

Purpose 

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. 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.

The QA Systems and Compliance Team with work closely with the Operations, Engineering, Validation, Supply Chain and AR&D Functions to ensure compliance to Global and Regulatory Quality Management System requirements as they pertain to the Quality Manual, Change Control, Deviation Management, Supplier Quality Management, Quality Risk Management, Audit Management and associated electronic systems.

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
• 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 in BioNX.
• 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

Requirements 

• 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.
• Previous experience in QRM, SQM, Deviations and Change Control, participating in investigations and problem solving.
• Strong attention to detail and precision in preparing and reviewing GMP documentation.
• Previous experience in quality management systems such as Veeva, SAP, Delta-V, TrackWise, PAS-X etc. or similar
• Strong written and verbal communication skills.
• Ability to think logically and be proactive under pressure.
• Ability to work as part of a team and on own initiative in a constructive manner.
• Knowledge of major Health Authority Guidelines and Regulations related to Biologics and/or Pharmaceuticals.
• Bachelor’s degree, or higher, in a Life Science discipline