Quality Specialist – Hybrid RoleMake sure to apply with all the requested information, as laid out in the job overview below.We are currently seeking to recruit a Quality Specialist for a leading Pharmaceutical Manufacturer within the Munster region.
The successful candidate will become a key member of the Global Development Team supporting all related QA activities.Responsibilities* Review and approve production and analytical documentation accompanying the release of drug substance, drug product and packaged finished goods to ensure conformance to appropriate SOPs, GMP and regulatory requirements, including supporting QP certification.* Actively communicate and collaborate with functional areas to develop a strong working relationship and understanding of roles and responsibilities.
Utilise this network to help resolve comments and issues that arise during audit and review.* Support product recalls and stock recoveries as appropriate.* Identify compliance gaps and make recommendations for continuous improvement* Creates and maintains assigned SOPs.* Perform and review complaints and deviation investigations, change controls and CAPA's.* Compiles data for reports and presentations - May interpret data and draw conclusions.* Completes audits of data, information, procedures, facilities, equipment and systems to ensure compliance to SOPs, GMPs and applicable regulations.
xsokbrcQualifications and Experience* Degree in an Engineering or Science discipline.* Significant experience within the pharmaceutical industry* Strong communication skills both written and oral