QP – Qualified Person
Job ID: JOB-11519
My client a leading pharmaceutical manufacturer of both medical and pharma products is recruiting for a QP on a permanent basis at their Galway site.
The role is to assist in the process of maintaining compliance to Product Licences / Marketing authorisations and batch certification accordingly.
In this role you will report to the Senior QA Compliance Manager/QP
- Responsibility for batch release as per EU guidelines by ensuring the requirements have been met
- The batch and its manufacture comply with the provisions of the marketing authorisation (including the requirements for importation where relevant);
- Manufacture has been carried out in accordance with GMP (in the case of an imported batch that it has been manufactured to standards equivalent to EC GMP);
- The principal manufacturing and testing processes have been validated (account has been taken of the production conditions by review of the relevant documentation);
- Any deviations or planned changes have been duly Any changes requiring variation to the marketing authorisation have been notified and authorised by the relevant authority.
- All necessary production and Quality Control documentation has been completed and endorsed by the appropriate staff;
- All audits have been carried out as required by the QA system;
- Conduct Routine Quality Audits of the facility to ensure compliance with current EU GMP, be proactive in resolving issues
- Set up and maintain the Internal Audit schedule and ensure its completion
- Conduct External audits, compile External Audit reports and manage associated
- Management and assistance with the site change control
- Provide technical support for New Product Introductions and existing Products, ensuring compliance with the registered dossier
- Provision / Updating of existing Quality Manual Procedures in order to ensure compliance with EU GMP
- Perform 3rd party management activities, including audit of suppliers and contract resource organisations, utilizing third party assessment
- Review and approve process and cleaning validation protocols and reports
- As a Qualified Person, is personally accountable to conform to the legal regulatory requirements as stated – Directives 2001/20/EC and Article 51 of Directive 2001/83/EC.
- Minimum 2 years’ experience in a similar role
- Experience of implementing and maturing a quality management system
- Proven experience in change and project management
- Ability to develop and lead continuous improvement initiatives
- Experience of direct line management
- Organizational skills, personal efficiency, time management skills and the ability to prioritize competing demands are key communication
- Ability to lead a team and to build relationships and collaborate
- Practical, action-orientated approach to managing priorities
For further information on this role please contact Clara Burke on 086 816 8273/ firstname.lastname@example.org
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