Job Description
QA Specialist urgently required for a busy Pharmaceutical Manufacturing site in Cork. Experience of Batch Record review, Projects and Operations. Would suit someone with at least 3 years experience gained within a Pharmaceutical Operations environment. Apply today for more details Duties Batch Record Review & material release. 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. ESSENTIAL- Quality Assurance Specialist-QA Operations: Bachelors Degree in a scientific/technical discipline require 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. Skills: quality specialist QA BATCH Review Projects validation Compliance