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Qa Complaince Specialist
4 weeks ago
Qualified Person is responsible for ensuring that each individual batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, in accordance with the requirements of the Product Specification File (PSF)/Marketing Authorisation (MA) and with Good Manufacturing Practice (GMP) for products manufactured at our clients Biologics site.
To ensure that products manufactured at our clients biologics site are manufactured in accordance with the relevant GMPs.
The Quality Assurance Specialist / Qualified Person (QP) is responsible for the disposition of bulk product manufactured at site as acceptable for release or reject based on the information available relating to the manufacture and testing of the product.
To disposition bulk product as acceptable for release, or reject, to ensure patient safety based on the information available relating to the manufacture and testing of the batch.
Requirements: Third level qualification in a science discipline with 5 years' experience in the pharmaceutical industry.
MSc in Industrial Pharmaceutical Science or similar course recognized by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC 5 years industrial experience gained in an FDA and EMEA approved pharmaceutical environment.
2 Years experience gained within an aseptic processing environment, ideally gained within a quality function.
For a confidential conversation about the role contact Owen Clancy at or By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purpose
