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Xeolas Pharmaceuticals
Quality Assurance OfficerXeolas Pharmaceuticals • Dublin, Leinster, Republic of Ireland
Quality Assurance Officer

Quality Assurance Officer

Xeolas Pharmaceuticals • Dublin, Leinster, Republic of Ireland
23 days ago
Job description
MAIN PURPOSE OF THE JOB: To be involved in all aspects of Quality relating to the Quality and Operations departments, working in compliance with current GMP standards and EU regulations. Involvement in the Research & Development sphere of the company as required. EDUCATION AND EXPERIENCE: BSc in Science or related field Experience working in finished product pharmaceuticals/biologics, including analytical chemistry, quality assurance, quality control, development, and/or manufacturing areas. Thorough understanding of quality systems and cGMP's. MAIN DUTIES OF THE JOB Compliance Ensure through monitoring, that the Production, Quality Control, Supply Chain and Engineering departments and procedures are maintained in accordance with current good manufacturing practice. Support Role Provide QA support and knowledge to the Production, Quality Control, Supply Chain and Engineering departments. Assess and advise on deviations and other issues as appropriate within the relevant departments. Inspections of cleandown, as required, Performance of line clearance as required. Documentation Review of batch records in preparation for QP disposition, while following the companys procedures in respect to data governance and integrity. Initiate updates to Standard Operating Procedures as required. Issuance of batch documents. Issuance of other controlled documents. General Assist in the preparation of customer and regulatory audits. Performance of self-inspections and preparation of internal audit reports. Maintenance of the supplier qualification system. Involvement in vendor complaint investigation. Involvement in customer complaint investigation and other customer queries. Involvement in deviation investigations. Involvement in change control system. Involvement in projects from a Quality Assurance prospective. Involvement in validations from a Quality Assurance prospective. Ownership of the archiving system. Maintenance of the deviation and internal audit spreadsheets. This is a guideline and is not intended to be all encompassing. RELATIONSHIP TO OTHER FUNCTIONS/ROLES: Liaison with Laboratory, Production, Supply Chain, and Engineering departments and external organisations as required.
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Quality Assurance Officer • Dublin, Leinster, Republic of Ireland

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