Dunboyne, Ireland | Posted on 07/15/2025
* 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 founded in 1996, headquartered in Pomona, California, USA, with global operations in Ireland, India, Singapore, Australia, and the US. We serve 350 clients across more than 23 countries, providing cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceutical contract manufacturing, and metrology services.
Career Opportunity
Join our team as a Qualified Person in our state-of-the-art Biologics facility in Ireland. This role offers the chance to work with cutting-edge technology and be part of a dynamic, collaborative environment in the biotech industry.
Requirements
Role Functions:
* Perform Qualified Person (QP) duties, certifying batches for release per EC directives including 2001/83/EC, Annex 16, and Annex 13.
* Ensure manufacturing and testing comply with cGMP and relevant regulations.
* Manage deviations and investigations related to drug substance manufacture and testing.
* Review and approve change requests impacting product quality and compliance.
Experience, Knowledge & Skills:
* At least 5 years of EU QP experience certifying batches according to EU directives.
* Comprehensive knowledge of GMPs, regulations, and industry trends.
* Strong communication, decision-making, and project management skills.
Qualifications & Education:
* EU QP qualification with minimum 5 years of relevant experience.
* BSc or higher in Biotechnology, Chemistry, Biology, or related field.
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