Qa Specialist Job In Cork

QA Specialist required for Pharmaceutical Manufacturing site in Cork. 3+ years experience in Pharmaceutical Operations environment.

Key responsibilities:

• Batch Record Review & material release
• Management of batch records design and approval
• Administration of SAP Quality Management Module
• Management of site change control systems
• Annual Product Reviews
• Supports validation activities on site
• Approves and compiles validation protocols and reports
• Supports system qualification and process validation activities
• Reviews and approves SOPs/work instructions/forms
• Coordinates regulatory and customer GMP inspections
• Participates in New Product Introduction Team
• Performs GMP audits and on-floor walkdowns
• Administration of site supplier approval process

Requirements:

• Quality Assurance Specialist-QA Operations: Bachelors Degree in scientific/technical discipline
• Minimum 3-5 years experience in quality, validation or compliance role
• Knowledgeable of FDA/EMEA regulatory requirements
• Skills: quality specialist QA BATCH Review Projects validation Compliance