CY Partners have an exciting opportunity for a Qualified Person, to join the Pharma R&D Team, at a world leading Healthcare Organisation, based at their site in Essex. As a QP you will have responsibility for delivering effective, safe and compliant leadership and management of the QA function.
As QP, you will have the opportunity to perform the quality assurance activities and quality oversight of the GMP functions performed within Pharma R&D, Fulfilling the Qualified person responsibilities defined 2001/20/EC and Article 51 of Directive 2001/83/EC. (including Release of Product into the EU which has been manufactured outside EU).
Key Responsibilities include, but are not limited to:
* Developing and incorporating effective processes and procedures in Product Quality Pharma R&D and may contribute to business processes and procedures outside Product Quality Pharma R&D
* Assuring products meet regulatory requirements and that they conform to regulatory submissions.
* Identifying business or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions.
* Providing advice and consultancy to project teams and external partners to reduce regulatory risk to the business.
* Identifying and mitigating compliance risks through effective assessments and/or via providing advice and consultancy to Product Quality Pharma R&D and business units regionally and globally.
* Liaising with customers to provide compliance advice/input.
Other responsibilities may include:
* Representing the group as a primary business contact for specific areas.
* Interacting with regulators.
* Participate in/manage routine audits/assessments as well as multiple projects of high priority including regulatory inspections and high risk non-compliance issues.
For an informal confidential chat about this role, contact Helen Tomlinson at CY Partners. Alternatively, you can apply through the link with an updated version of your CV.
Tagged as: GMP, Inspections, Product Quality, QP, Qualified Person, regulatory
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. CY Partners Recruitment Ltd, trading as CY Partners is an Employment Business/Agency
- Business Processes
- Quality Management
- Regulatory Requirements