Dublin, Ireland - Permanent Full Time Role
Xeolas is an Irish-owned speciality Pharmaceutical company located in Dublin, Ireland with 65+ employees. We develop and manufacture innovative patient-friendly pharmaceutical products for international markets. We are now seeking an experienced Quality Assurance Senior Specialist as we expand our Quality Assurance department.
Overall Role Objective 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. Actively foster, in cooperation with other staff, a Quality ethos and culture. Involvement in the Research & Development sphere of the company as required. Deputy for the QA Manager.
Reporting To Quality Assurance Manager
Specific Responsibilities Compliance: Management of key elements of the Quality Management System (QMS), which includes but is not limited to; inspection management, metrics/KPIs, Quality management review, product quality communications, Product Complaints, Risk Management and Regulatory 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. Documentation: Develop and update Standard Operating Procedures as required. Issuance of Batch documents. Issuance of other controlled documents. General: Involvement in the QA Training System. Involvement in the Annual Product Quality Review. Involvement in the Change Control System. Participation during Customer and Regulatory Audits. Performance of Self Inspections and preparation of internal audit reports. Maintenance of the Supplier Qualification System. Involvement in Customer Complaint investigation and other customer queries. Involvement in Deviation investigations. Involvement in Projects from a Quality Assurance perspective. Involvement in Validations from a Quality Assurance perspective. 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.
Key Skills / Experience Requirements For this role, we're looking for a candidate who has an effective combination of the following qualifications, skills and experiences:
Education and Experience: BSc in Science or related field. A minimum of 6 years working within quality in the pharmaceutical industry. 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. Excellent verbal and written communication skills. Be self-motivated, flexible, organised and a good team player with the ability to prioritise own work based on departmental and site requirements. Work directly with other key departments to ensure compliance and productive working relationships. Apply for this Job Please send a cover letter and your CV to
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