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:
This role will be part of our Quality Assurance Team inour state of the art single use multi-product biotech facility in Ireland.
Requirements
Role Functions:
* An exciting opportunity has arisen for an experiencedQualified Person to join our Quality department at our Biologics facility
* Our facility is a premier, state-of-the-art facility thatenables and advances our best work. By integrating leading-edge technology witha dynamic, activity-based workspace, the facility will support seamlessconnection and collaboration within and across teams and functions.
Responsibilities:
* Perform Qualified Person (QP) duties in certifyingbatches for release in accordance with the relevant EC Directives including2001/83/EC, Annex 16 and Annex 13 of the EU Guide to Good ManufacturingPractice and Company Procedures.
* Assure batch manufacturing and testing has been performedin accordance with cGMP and the relevant marketing authorization (MA) orclinical trial authorization, product
* specification file, legal obligations and/or technicalagreement. Manage and/or escalate any potential CGMP and/or other concerns in atimely manner.
* Provide oversight of deviations (including approval ofsignificant deviations) and laboratory investigations related to drug substancemanufacture, testing and those that may present potential effect on product and/or material.
* Confirm change requests with product impact which requireexpanded review (e.g., regulatory, stability, testing impact) have beenappropriately reviewed, approved and technically closed.
Experience, Knowledge & Skills:
* EU QP Qualification and experience (at least 5 years) ofcertifying batches for release in accordance with the relevant EC Directivesincluding 2001/83/EC, Annex 16 and Annex 13 of the EU Guide to GoodManufacturing Practice and Company Procedures.
* Expert level of knowledge of relevant GMPs, regulationsand current industry trends.
* Communication, decision making, people influencing andproject management skills. Problem-solving / critical thinking – ability tounderstand connections between different technical/quality system areas andrecognize potential compliance issues.
Qualifications & Education:
* EU QP Qualification and experience (at least 5 years) ofcertifying batches for release in accordance with the relevant EC Directivesincluding 2001/83/EC, Annex 16 and Annex 13 of the EU Guide to GoodManufacturing Practice and Company Procedures.
* BSc. degree (or higher) in Biotechnology, Chemistry,Biology or in a relevant discipline.
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