Quality Assurance Specialist

Collins Mcnicholas Recruitment

Cork

Role Responsibilities: 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. Executes 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. Role Requirements: Essential: Bachelor’s Degree in a scientific/technical discipline required. A minimum of 3-5 years’ experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry. Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position. Demonstrated knowledge and application of industry regulations as they apply to quality, including those of FDA, IMB, EMEA and other authorities. Desirable: Experience in auditing of external suppliers, contractors and vendors. For a confidential discussion and more information on the role, please contact Josh Barnes on 021-4911066 or email josh.barnes@collinsmcnicholas.ie. For more information on our Recruitment and HR Services, and to see a full list of our available jobs across Ireland, please visit our website at www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our consultants to discuss all the latest jobs! This job originally appeared on RecruitIreland.com.

1799 days ago