Quality Systems Specialist Job

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Quality Systems Specialist

Job Posted: 24 days ago

  • Salary: Competitive

    Job Type: Contract

  • Location: Tipperary, County Tipperary

Expire in: 4 days

Job Description

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
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