The QA Manager Sterile Fill Finish is responsible for all aspects of the assigned QA Team and. Provides QA oversight to ensure that all drug product manufacturing activities are compliant with company policies, procedures and in accordance with cGMPs.
The successful candidate will have minimum 8 year's experience in the biopharmaceutical industry.
- Support the Head of Quality with the quality function oversight
- Maintain the EirGen Pharma, Pharmaceutical Quality System to include: Personnel, Premises & Equipment, Production, QC, Outsourced activities, Complaints, Investigations, Self-Inspections
- Ensure all work carried out is compliant with company standards, cGxP, SOPs, regulations and guidelines, safety and environmental guidelines
- Continuously promote a positive safety culture. Implement Safety requirements as per site documentation including SOPs, Safety Statement
- Collaborate cross functionally with all departments and represent Quality on the Sterile Supply Value Stream - Investigations management and approval a. Deviations & Complaints b. Out-of-Specifications, Out-of-Calibrations, Out-of-Trends
- Elevate Quality issues to the Head of Quality and Senior Management where required, working collaboratively with the Sterile Fill Finish Manager to provide direction and support in critical interventions
- Manage Self Inspection Program
- Manage and host site Inspections (Customer audits / Regulatory inspections etc.)
- Batch documentation review ensuring compliance to standards and SOP's - Batch package preparation for QP release
- Manage Vendor Qualification
- PI and excipient disposition
- Primary & Secondary component disposition
- Provide oversight of any Contract Manufacturing activities related to Sterile Fill Finish
- Manage metrics, performance and review with the Site Leadership Team
- Quality management representative on EirGen's Area Management Team , ensuring effective running of the business
- Involved in the recruitment, leadership and career development of Quality Assurance members
- Creation of Quality department goals aligned with site strategy and objectives
- Performance evaluations for direct reports - Quality department budgeting
- To perform additional tasks as agreed to support effective running of the business.
- Primary degree in a scientific discipline
- Minimum 8 years' experience in the biopharmaceutical industry, 5 of which should be within a Quality function
- Minimum 4 years leadership experience, including team coaching and development
- Experience of Quality Assurance of aseptic medicinal products and in particular biopharmaceuticals.
- Experience in using lean methodologies and / or operating within Value Streams
- Candidate is eligible to act as a Qualified Person as described in EU Directives, would be an advantage
- Extensive knowledge of electronic QMS systems - EDMS, ERP, TrackWise etc.
- Experience preparing and hosting Customer & Regulatory Inspections
- Lead auditor experience
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.