Job Opportunity: Quality Assurance Specialist
Are you a highly motivated and detail-oriented individual with a passion for quality assurance in the pharmaceutical industry? We are seeking a skilled Quality Assurance Specialist to join our organization on a contract basis.
About the Project
We are working with a leading biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines that can help patients overcome serious diseases and improve their quality of life.
* Compilation and review of batch release dossiers for Qualified Person certification of medical products to clinical trials.
* Updates and maintains the site Manufacturing and Importation Authorisation (MIA) in accordance with regulatory requirements and maintains the Site Master File.
* Generates and maintains Product Specification Files (PSF) for medical products.
* Provides QA support and oversight of packaging and labeling operations for medical products.
* Supports the generation and ongoing maintenance of Quality Agreements.
* Provides Quality Assurance support in the Use Date Extension process.
About You
To be successful in this role, you will have:
* A degree in science, engineering or related discipline is essential along with 3 years' experience in a role within the pharmaceutical/pharmaceutical industry.
* Demonstrated strong knowledge of ICH/GMP, data integrity, regulatory guidelines/directives, clinical supply chain processes and principles of Quality Assurance.
* Excellent communication and organizational skills, with the ability to work independently as well as part of a team.
* The ability to work across a team matrix in order to meet accelerated timelines.
Applicants interested in our contracting opportunities within the pharmaceutical sector in Ireland are required to have a Stamp 1G or a Stamp 4 visa. Please note that we are unable to provide visa sponsorship.
What We Offer
Our organization offers a unique opportunity for career growth and development in the pharmaceutical industry. Our team is passionate about improving patient outcomes through high-quality medical products and services.
How to Apply
If you are a highly motivated and detail-oriented individual with a passion for quality assurance, please submit your application for consideration.