Dunboyne, Ireland | Posted on 07/11/2025
* Industry Pharma/Biotech/Clinical Research
* Work Experience 4-5 years
* City Dunboyne
* State/Province Meath
* Country Ireland
Job Description
About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide. We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.
‘Take your Career to a new Level’
PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry. We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.
Employee Value Proposition
Employees are the “heartbeat” of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression. We believe in creating high performing teams that can exceed ourclient’s expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.
Overview:
* An amazing opportunity has arisen for a SupportOperations Quality Notifications and Investigations Specialist to provideoperational support for manufacturing operations of our Late Stage and LaunchPipeline products at our new state of the art single use biotechnology facility.
* Our facility is apremier, state-of-the-art facility that enables and advances our best work. Byintegrating leading-edge technology with a dynamic, activity-based workspace,the facility will support seamless connection and collaboration within andacross teams and functions. Our facility will provide Biologics Drug Substancemanufacturing for Clinical Supply, Registration & Commercial Launch.
* The facility is designed to be operated in amulti-product mode which requires flexibility to adjust as the pipeline ofclinical and commercial biologics-based medicines demands change.
* Our facility serves as a magnetic force that attracts,recognizes, and integrates people of diverse backgrounds and perspectives.Employees will feel not only that they belong in the Team, but that thefacility belongs to and is shaped by them.
* This could be either a 6-month or an 12-month project, depending on the final scope and requirements.
Reports to:Drug Substance Support OperationsAssociate Director
Requirements
Responsibilities:
* Author Quality Notifications: Take full ownership ofdrafting, reviewing, and finalizing Quality Notifications, ensuring clarity,accuracy, and compliance with regulatory requirements.Initiate and maintain quality relatedmetrics related to Quality Notifications ensuring effective communication andfollow up of the same.
* Quality Metrics: Ensure that Quality notifications(including CAPAs, Investigations and incidents) meet our metrics for raised ontime and closed on time, while maintaining a high standard of technical writingand compliance.
* Incident Reporting: Solely manage the authoring ofincident reports, documenting quality issues and ensuring timely submission forreview and approval.
* Investigations Documentation: Lead the authoring ofcomprehensive investigation reports, detailing findings, root cause analyses,and corrective actions.
* Approval Process Management: Navigate the approvalprocess for all authored documents, collaborating with cross-functional teamsto ensure timely reviews and compliance with quality management systems.
* Quality Risk Assessments: Participate in Quality RiskAssessments as needed, providing insights and documentation to support theevaluation of quality risks.
* Continuous Improvement: Contribute to a culture ofcontinuous improvement by identifying opportunities for enhancing documentationprocesses and quality practices.
* Compliance Adherence: Ensure all authored documents meetthe necessary compliance standards and are aligned with the ManufacturingDivision Quality Management Systems (QMS).
* Training and Support: Provide guidance to team members onbest practices for documentation and compliance, fostering a culture of qualityawareness
Skills & Education:
* Bachelor’s degree in Biotechnology, Chemistry, Biology,Pharmacy, or Process engineering.
* 2 years + experience in Biotech Industry (bulkmanufacturing of pharmaceutical or biological components). Position level will scale withexperience level of candidate.
* Strong technical writing capability and previousexperience authoring reports and investigations in a GMP environment
* Competent in analysing complex situations and showpractical problem-solving capabilities.
* Ability to work independently and within across-functional team.
Preferred Skills:
* Experience in leading and facilitating Root CauseAnalysis and Quality Risk Assessment sessions
* Experience supporting Regulatory Inspections and SiteInternal Audits
* UnderstandingofUpstream and Downstream Unit Operations for mAb manufacturing
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