Location: Cork Role: Permanent
Leading Healthcare company require a QP to join the QA team.
This candidate will act as a Qualified Person as per Article 13.3 of the European Directive 2001/20/EC.
The primary job function will be the QP release of finished products against EU legislation. Acting within a team of QPs, duties are expected to encompass the following:
QP certification of manufactured bulk finished product for release to packaging operations.
QP certification of finished product in final packaging for release to the market.
Ensuring compliance of processes, systems and procedures in accordance with EU/FDA/PMDA and all other applicable country legislation.
Support QA/QP scheduler in planning and scheduling of the QP resource to ensure maintenance of operating capacity.
Provide leadership, guidance and advice to Production & Packaging and Supply Chain with respect to QP release of bulk and finished products.
Approve QP to QP agreements
Maintain knowledge of contemporary legislation and subsequent changes; communicating to the QP team.
Provides QA GMP support and technical direction to QA platform teams, ensuring that all aspects of the quality oversight are performed.
Partner and ensure alignment with the other global QA teams in order to provide effective QA support for the partner lines on a global level.
Partner with QPs and the other global team leaders to ensure timely disposition of all artwork requirements.
Must be eligible to act as a QP under the relevant requirements of current EU Directives
Must have a minimum of 5 years experience working in the pharma industry and Must have experience of acting as a QP at a licenced facility
Must have proven experience with working in a team/partnership with business, working to tight deadlines and GMP