Quality Systems Specialist
2 days ago
The role: PE Global is currently recruiting for a Senior QA Compliance, Quality Systems on behalf of a leading pharmaceutical company based in Meath. This is an initial 11-month contract role. This role is a hybrid role. Job 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. Key Accountabilities Accountabilities include but are not limited to the following: 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 Bachelors degree, or higher, in a Life Science discipline 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. Interested candidates should submit an updated CV. Please click the link below to apply, call Audrey on or alternatively send an up to date CV to ***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland*** Although it is not possible for us to respond to all applications, we at PE Global will do our upmost to give you feedback on your application. You have sent your Cv into us as a company and even though you have sent your CV to a particular position, we are making the reasonable assumption that you are active on the job market and as part of our normal recruitment service we will discuss other suitable positions with you. You are free to opt out of this so please specify in your application to us if you just want to be contacted in relation to a specific vacancy. Your Cv is sent to a central recruitment inbox which a number of people in the applicable PE Global division have access to and so this means that you might not be contacted by the named person in this advert. Skills: QMS Deviations Change Control
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