Quality Systems Specialist

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