Pharmaceutical Compliance Specialist

3 days ago

Sligo, Sligo, Ireland beBeeCompliance Full time €60,000 - €80,000
Job Overview

We are seeking a highly skilled Pharmaceutical Compliance Specialist to join our team in Ireland. This is an exciting opportunity for someone who is passionate about ensuring the highest standards of quality and compliance in the pharmaceutical industry.

Key Responsibilities:
  • Ensure that all manufacturing processes comply with EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use Annex 16: Certification by a Qualified Person and Batch Release;
  • Verify 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;
  • Determine whether bulk product is acceptable for release or reject, to ensure patient safety based on the information available relating to the manufacture and testing of the batch.
Required Skills and Qualifications:
  • A third-level qualification in a science discipline with extensive experience in the pharmaceutical industry;
  • An MSc in Industrial Pharmaceutical Science or similar course recognised by Regulatory Authority to permit Qualified Person (QP) status as per Article 49 of Directive 2001/83/EC;
  • Extensive industrial experience gained in an FDA and EMEA approved pharmaceutical environment.
Benefits:

This role offers a competitive salary and a comprehensive benefits package, including opportunities for professional development and growth.

What We Offer:

We are committed to providing a safe and supportive work environment that fosters collaboration and innovation. Our team is dedicated to delivering high-quality products that meet the needs of our customers and patients.

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