Quality Systems Specialist

An opportunity has arisen for a Quality Specialist to support the Quality Systems activities in both the Drug Substance and Drug Product facilities within a leading Biopharma Multinational based in the North Munster region.

Key Responsibilities:

• Provide leadership, regarding the validation standards required for Process, Cleaning, Water and Equipment.
• Principle Quality contact for all Quality assessment of material control strategies associated with change requests for processing and analytical changes.
• Laboratory QA oversight
• Manage the site inventory of Quality Agreements to ensure Quality Agreements are raised for all required relationships.
• Annual Review System Management
• Creation, review and approval of Site Quality documentation including
• Review and approve Supplier Change Evaluation documentation.
• Investigate Supplier and Customer complaints
• Filing & Licence maintenance and Regulatory Requests follow ups
• Review and verify documentation that may be used for submission to Pharm - CMC or other requester(s) for regulatory submissions/filings
• Support the internal GMP walk-down and scheduled audits programme

Qualifications and Experience

• Minimum of Degree or post-graduate qualification in Science, Pharmacy or Engineering field
• 3+ Years relevant experience within the pharma/biotech industry.
• Strong Communication skills both written and oral
• Pro-active approach
• Planning and scheduling experience
• Customer service skills
• Interpersonal Skills