Job Title: QA Systems (Hybrid)
We are currently recruiting a QA Systems (Hybrid) on behalf of our Multinational Biopharmaceutical Client based in Co. Meath.
This is an initial 11-Month contract with potential to extend.
About the Role
The QA Systems and Compliance Team will work closely with the Operations, Engineering, Validation, Supply Chain and AR&D Functions to ensure compliance to Global and Regulatory Quality Management System requirements.
* 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.
Educational and Experience 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.
Salary
$85,000 - $115,000 per year, depending on experience.