Headcount Solutions | 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 Skills: Quality Systems QA Pharmaceutical Biotech