Sr Quality Systems and Compliance Specialist
Dunboyne, Ireland | Posted on 12/16/2024
* Industry: Pharma/Biotech/Clinical Research
* Work Experience: 5+ years
* City: Dunboyne
* State/Province: Meath
* Country: Ireland
Job Description
About PSC Biotech
PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.
Employee Value Proposition
Employees are the "heartbeat" of PSC Biotech. We provide unparalleled empowering career development through Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high-performing teams that can exceed our client’s expectations regarding the quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.
The purpose of this role is to work within and support the Global Development Quality Assurance team at the 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 the 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 the start-up schedule.
The QA Systems and Compliance Team will work closely with the Operations, Engineering, Validation, Supply Chain, and AR&D Functions to ensure compliance with 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.
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 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.
* 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 with 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.
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. This role is a hybrid role.
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