Direct message the job poster from Sterling Engineering Ltd - Ireland & Europe
Recruitment Team Lead at Sterling Engineering - Ireland & Europe - 086 190 8885
Position: Quality Assurance Specialist/QP
Location: Sligo
Contract Role - 12 months
Salary: €80-100 per hr
Responsibilities:
* Ensure compliance with EudraLex Volume 4 EU Guidelines for Good Manufacturing Practice (GMP) for Medicinal Products for Human and Veterinary Use, specifically Annex 16: Certification by a Qualified Person and Batch Release, and Article 47 of Directive 2001/83/EC.
* As the Qualified Person (QP), verify that each batch has been manufactured and tested in accordance with applicable legislation in the Member State where certification occurs, and in line with the Product Specification File (PSF)/Marketing Authorisation (MA) and GMP requirements.
* Ensure that all products manufactured on site adhere to relevant GMP standards.
* As the Quality Assurance Specialist / Qualified Person, be responsible for making final decisions regarding the release or rejection of bulk product manufactured on site, based on available manufacturing and testing data.
* Make disposition decisions—either release or reject—for bulk product batches, ensuring patient safety remains the primary consideration.
* Adhere to Environmental, Health and Safety (EHS) policies and procedures, and consistently demonstrate best practices in all work-related activities.
Requirements:
* Third-level qualification in a scientific discipline, along with a minimum of 5 years’ experience in the pharmaceutical industry.
* Possession of an MSc in Industrial Pharmaceutical Science or an equivalent qualification recognized by the Regulatory Authority to support QP eligibility, in line with Article 49 of Directive 2001/83/EC.
* At least 5 years of experience working in a pharmaceutical environment approved by both the FDA and EMEA.
* A minimum of 2 years' experience in an aseptic processing environment, preferably within a quality function.
* A high level of expertise in evaluating day-to-day quality-related issues is essential.
* Ability to quickly develop in-depth knowledge of site products and processes to effectively assess quality matters.
By applying to this job post you agree that Sterling Engineering may process your personal data for recruitment purposes.
For more information and a confidential chat please contact Gerard Cunniffe on +353861908885.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Contract
Job function
* Job function
Quality Assurance
* Industries
Pharmaceutical Manufacturing
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