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Job Description
QA Specialist required for Pharmaceutical Manufacturing site in Cork. Key responsibilities include batch record review, project management, and quality assurance.
Key Responsibilities:
- Batch Record Review & material release
- Management of batch records design and approval
- Administration of the SAP Quality Management Module
- Management of site change control systems
- Compiles Annual Product Reviews
- Supports all validation activities on site
- Approves and compiles validation protocols and reports
- Reviews and approves SOPs/work instructions/forms
- Coordinates regulatory and customer GMP inspections
- Performs GMP audits and on-floor walkdowns
- Administration of site supplier approval process
Requirements:
- Bachelors Degree in a scientific/technical discipline
- Minimum 3-5 years experience in quality, validation or compliance role
- Knowledgeable of FDA/EMEA regulatory requirements
- Quality specialist with experience in batch review, projects, and validation