Job Title:
Bulk Product Specialist
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Description:
We are seeking an experienced Bulk Product Specialist to join our team. As a Bulk Product Specialist, you will be 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.
This role requires strong analytical skills, attention to detail, and the ability to work effectively in a fast-paced environment.
The ideal candidate will have experience working in a pharmaceutical environment, specifically in aseptic processing, and hold a third-level qualification in a science discipline.
In this role, you will be 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 be successful in this role, you must have excellent communication skills, be able to work independently, and be able to prioritize tasks effectively.
Responsibilities:
* Ensure compliance with Eudra Lex Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 16: Certification by a Qualified Person and Batch Release;
* Article 47 of Directive 2001/83/EC;
* Manage the disposition of bulk product manufactured at site;
* Determine the suitability of products for release or rejection;
Requirements:
* Third level qualification in a science discipline;
* 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;
* Experience gained in an FDA and EMEA approved pharmaceutical environment;
* Experience gained within an aseptic processing environment, ideally gained within a quality function;
Benefits:
This is an excellent opportunity to develop your skills and expertise in a dynamic and challenging environment. You will have the opportunity to work with a highly experienced team and contribute to the success of the company.
We offer a competitive salary and benefits package, including opportunities for professional development and career advancement.
About Us:
We are a leading provider of engineering consultancy services, specialising in project management, talent solutions, and commissioning qualification and validation services. We partner with many of the world's largest life science & technology companies who entrust in us to deliver their most strategic and important projects.
We are committed to delivering high-quality services and exceeding our clients' expectations. Our team is dedicated to providing exceptional customer service and building long-term relationships with our clients.