Qualified Person (QP)- Part-Time
Dublin, Dublin North
QUALIFIED PERSON (Part-Time. (12 month FTC, 3 days/week. A Qualified Person is required on a part-time basis, typically 16-24 hours/2-3 days per week. This role would be ideal for a candidate who wishes to work part-time and/or to job share. THE COMPANY: A pharmaceutical company with an extensive portfolio of cancer care products and a robust drug development pipeline. The client operates a state-of-the-art drug product development and manufacturing facility for the production of oral, solid and topical dosage forms. In addition, the company carries out final packaging of special dosage forms such as sterile forms and softgel. JOB PURPOSE: To support the Quality Assurance Manager in the day-to-day running of the QA department, with an emphasis on batch disposition and the support of related quality systems. RESPONSIBILITIES: • To act as a QP in the Batch Release group. • Certify medicinal product in accordance with requirements of product marketing authorization, EU Directive 2001/83/EC & 2001/20/EC and EU GMP Annex 16. • Assist in the coordination of the QA operational duties relating to product disposition. • Participate in investigations and risk assessments related to manufacturing deviations and changes and ensuring appropriate actions are implemented. • Ensure product release procedures comply with current regulatory and company requirements. • Coordinating deviation investigations, log trend deviations and issuing regular reports on such trends. • Acting as a point of contact for Production, Engineering, QC and Technical Affairs GMP issues. • Advising and providing input into quality systems across the plant. • Coordinating sampling activities for incoming materials. • Coordinating the release of packaging materials on completion of testing. • Coordinating the on-line inspections of packed product. • QA review of documentation, including SOP’s, worksheets, logbooks. • Any other related activities as indicated by the Quality Assurance Manager. REQUIREMENTS: • BSc Degree in a related discipline, along with MSc or Post Grad which leads to QP status. • Minimum of 1 years’ experience working as a QP on a manufacturing license. • Experience working within a pharmaceutical manufacturing environment in a Quality capacity (QA or QC. • Experience of Quality systems to include but not limited to deviation, out of specs, risk management. • Previous experience in a Pharma Solid Dosage environment would be beneficial. This job originally appeared on RecruitIreland.com.
74 days ago