Qualified Person

2 months ago

North West, United Kingdom Templarfox Full time

Qualified Person (QP) Recruiting for a new role as Qualified Person (QP) to join a leading contract manufacturing healthcare and pharmaceutical company based in the Wirral and who manufacture healthcare products under pharmaceutical and medical devices. As the Qualified Person (QP) you will be responsible for delivering batch disposition, Improving quality and compliance across the site and developing QMS. KEY DUTIES AND RESPONSIBILITIES: Your duties as the Qualified Person (QP) will be varied however the key duties and responsibilities are as follows: - Responsibility for batch release as per EU/UK guidelines by ensuring the requirements have been met - Actively Support the Quality function to ensure the strategy and operations continue to comply with the regulatory requirements by review and input as appropriate in all aspects and the Quality Management systems to include: - Validation - Incident reporting and non-conformance reporting - Complaints - Change Control - Risk Assessments - Supplier assurance - Liaise with customers as required, including support for new product introduction - Ensure 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);
- Conduct Routine Quality Audits of the facility to ensure compliance with current EU/UK GMP, be proactive in resolving issues - 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/UK GMP - Perform 3rd party management activities, including audit of suppliers and contract resource organisations, utilizing third party assessment Key Requirements - 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 - Proven experience in change and project management - Ability to develop and lead continuous improvement initiatives 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 If you believe you hold the relevant background experience and looking for a new role as Qualified Person (QP) within successful and growing business then this is the role for you. About us: Templarfox is a privately owned recruitment business leading in executive search, management selection, Salary benchmarking and Business development services. The recruiter has stated that all applicants for this job should be able to prove that they are legally entitled to work in the UK and on this occasion TemplarFox Consultancy is acting as an employment agency.

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