QA Distribution Specialist - Life Science - Contract - Dublin
Make a meaningful impact in the pharmaceutical industry by joining a pioneering organization committed to driving innovation. We are seeking a highly skilled QA Distribution Specialist to support our QA Distribution function.
Located just minutes from Dublin Airport and the vibrant Irish capital, this leading biopharmaceutical organization is at the forefront of technology on its cutting-edge manufacturing facility.
Key Responsibilities:
* Ensure quality oversight of temperature-controlled product activities worldwide, adhering to local and international regulations and schedules.
* Evaluate temperature-controlled shipments and make informed quality decisions regarding products.
* Serve as the primary quality technical contact point for distribution partners.
* Guide, 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.
* Maintain quality agreements with distribution contractors and carriers, supporting review meetings with these parties.
About You:
* Minimum 5 years of QA experience in a HPRA/FDA/EU & GMP/GDP regulated environment.
* In-depth knowledge of temperature-controlled product activities.
* Thorough understanding of cGMPs/GDPs and global regulatory requirements.