Job Description
QA Specialist RK0011 Contract 12 months Cork Were currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do. This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities as required by Good Manufacturing Practice (GMP). These activities include Incoming material release, Batch release, Change control, Event management, Supplier qualification, Annual product review and Validation compliance activities. Duties: 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. Performs on the floor walkdowns regularly to ensure process and facilities are maintained to GMP standards. Carries out tasks related to the administration of site supplier approval process. Experience and Education: Bachelors Degree in a scientific/technical discipline required 3-5 years experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry. Experience in auditing of external suppliers, contractors and vendors If interested in this posting please feel free to contact Rachel Kent on or for further information. Skills: Quality Assurance External Auditing New Product Introduction