My client is a global biopharmaceutical company focused on developing and delivering products to improve people's lives. They are seeking a QA Specialist to join their team based in Cork. This company has invested millions into their Cork facilities which shows their commitment to employees and the area. What's in it for you? This is a superb opportunity to work in a Quality Assurance environment for a global pharma that serve patients with life-improving treatments. Working here will be a fantastic addition to your CV. Your work will truly make a difference to people's lives and you will work alongside cutting-edge technology and a supportive and friendly team. General Responsibilities: Carrying out tasks and projects related to compliance activities during qualification and validation related to projects as required by Good Manufacturing Practice (GMP. Review and approval of change controls, non-conformance investigations, and protocols. Support and direct all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the Standard of Leadership behaviour model. Batch Record Review & material release to ensure compliance with GMP requirements. Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints. Carries out tasks related to the management of batch records design and approval. Carries out administration of the SAP Quality Management Module. Carries out tasks relating to the management of site change control systems. Compiles Annual Product Reviews. Supports all validation activities on site as described in the Site Validation Master Plan. Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.). Supports system qualification and process validation activities. Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance. Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site. Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI. Perform GMP audits on-site and vendor facilities as required. Carries out tasks related to the administration of site supplier approval process. The Fit: The ideal candidate will have a Third Level qualification in Science/Pharma with 2 years experience in a GMP Quality environment, or a combination of education and experience. Next Step: APPLY NOW. No updated CV or have some questions before applying? Call Leo for a confidential chat on 086 049 5443 or connect with me on: LinkedIn at http://bit.ly/2tm1My2 or Twitter: https://twitter.com/LeoRecruits. This job originally appeared on RecruitIreland.com.
193 days ago