QP (Qualified Person),Kent

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Qualified Person – Sandwich, Kent

A fantastic opportunity has become available for a certified Qualified Person (QP) to join a highly respected Contract Research Organisation for a client site in Sandwich, Kent.

I am currently recruiting for a Qualified Person (as per Article 13.3 of the European Directive 2001/20/EC).This global CRO industry leader work with global pharmaceutical companies delivering professional scientific services at the client site.

This QP role will provide you with an opportunity to work within a team of highly professional QP’s to assist in the manufacture and release of IMP batch material for clinical trial use.

Duties:

• QP release of bulk Drug Product and Finished Product for use in clinical trials


• Ensuring compliance of processes, systems and procedures in accordance with EU legislation.


• Support QA / QP scheduler in planning and scheduling of the QP resource to ensure maintenance of operating capacity.


• Review QP right first time metrics to ensure continuous improvement in the process.


• Provide leadership, guidance and advice with respect to QP release of clinical products.


• Issue QP Declarations of GMP compliance.


• Maintain knowledge of contemporary legislation and subsequent changes. Share knowledge with the wider QP team


• Provides QA GMP support and technical direction to 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 QA team leaders to ensure timely disposition of finished labelled supplies.


• Lead on interaction with partner lines by building relationships with the lines through early engagement and ongoing interaction / consultation.


• Maintain knowledge of GMP regulations, guidelines and their application in R&D and commercial environments and use this knowledge to lead and participate in investigation of product/facility deviations and investigations including root cause analysis.


• Escalate and/or cascade technical/quality issues to management.


• Host, participate and act as an SME in internal GMP audits and regulatory inspections (e.g. MHRA) of manufacturing facilities and systems and work to resolve audit observations as required.

Requirements

• You will be a, certified QP with experience in pharmaceutical manufacturing to EU and US standards


• Eligibility to act as a Qualified Person under EC Directive 2001/83 EC


• Bachelor’s Degree (B.S.), in Pharmacy, Chemistry, or Biology.


• Relevant work experience in a cGMP pharmaceutical manufacturing or R&D environment.


• Proven experience in leading complex GMP compliance investigations is preferred.


• Knowledge of US and EU current Good Manufacturing Practices is essential.


• Has extensive knowledge of scientific principles associated with drug development?


• Have a broad knowledge of principles and concepts of other disciplines and other disciplines and demonstrated experience as QP named on a pharmaceutical manufacturer’s site licence- essential.


• Expert in quality investigation techniques and advises or lead complete quality investigations and develop QA position/decision related to the quality role.

This is an outstanding opportunity to become a critical member of a high performing QA team, in a fantastic company. The company offer a competitive salary along with a range of benefits to include healthcare, pension, life assurance, training and development

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