Quality Manager – QP
Founded in 1945, this leader is a privately owned, medium-size, specialty pharmaceutical company. Its activities are focused on Western Europe. Since its inception, the company has expanded from its strong base in the Benelux countries to operate in other parts of Europe, notably France and Italy. The Group had a turnover in 2015 of approximately €105 million and employs approximately 300 staff in the Netherlands, France, Italy, Belgium and Ireland combined.
- Management of the Quality System in compliance to GMP and GDP requirements.
- Manage the batch disposition process ensuring timely release of a of product under the Manufacturer’s Authorisation.
- Management of all existing Therabel Pharmaceuticals Quality / Technical Agreements.
- Provision of Quality Oversight to Therabel Contract Manufacturers.
- Perform periodic audits of CMO’s independently or with other Therabel colleagues.
- Management of Change Control system.
- Management of the Deviation system.
- Management of Customer Complaints and Product Recall.
- Preparation, review and approval of Product Quality Review Reports.
- Management the Self-inspection programme.
- Management of the Stability programme.
- Update and maintenance of the Site Master File and Quality Manual.
- Maintenance of Manufacturer’s Authorisation and Wholesaler Distribution Authorisation.
- Support the preparation of submissions / variations to Regulatory Authorities.
- Management of Quality Consultants.
- Facilitate GMP and GDP inspections as necessary.
- Educated to degree level, with appropriate post graduate qualification, ideally in life science discipline.
- Extremely broad outlook on the pharmaceutical business gained from direct experience of Quality Management / Regulatory Affairs Management.
- Understanding and familiarity with EU GMP and GDP regulatory requirements, guidelines and expectations.
- Excellent understanding of validation, analytical methods, testing, stability and documentation systems as appropriate.
To learn more apply on line or call Shane Browne on +353 1 6321865.
Salary: On Application
Location: Dublin City Centre