Exciting Opportunity in Pharmaceutical Quality Assurance
We are seeking a skilled Quality Assurance Specialist to support the QA function in a leading biopharmaceutical organisation. Located near Dublin Airport, this state-of-the-art facility paves the way with innovative technology.
* Responsible for quality oversight of temperature controlled product activities, ensuring products shipments comply with GDP requirements.
* Assess temperature controlled shipments and provide quality decisions on product.
* Act as primary quality technical contact point with distribution partners.
* Provide guidance, drive and monitor quality issues related to temperature controlled products and GDP to resolution within the company and with external parties.
* Review documentation including change controls, deviations, validation documentation, SOPs and specifications.
* Ensure quality agreements with distribution contractors and carriers are established and maintained. Support the conduct of quality and operations review meetings with Distribution contractors.
About You:
* Minimum 5 years QA experience in a HPRA/FDA/EU & GMP/GDP regulated environment.
* Thorough knowledge of temperature controlled product activities.
* Thorough knowledge of cGMPs/GDPs and global regulatory requirements.