QA Specialist

QA Specialist urgently required for a busy Pharmaceutical Manufacturing site in Cork. Experience of Batch Record review, Projects and Operations. This role would suit someone with at least 3 years experience gained within a Pharmaceutical Operations environment.

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.