Qualified Person - 12 Month Contract

I have am currently recruiting for a Qualified Person to join a global pharmaceutical organisation based in West London for a 12 month contract to start in November.

In addition this position is responsible for providing leadership and direction for contractors who provide manufacturing and logistics services. Products are for commercial and named patient supply use only.

1. Skills/Knowledge Required

*BSc (or equivalent) in a technical or scientific discipline which meets educational requirements as described in Article 49 2001/83/EC *Eligible to act as Qualified Person within EC/EEA *Extensive pharmaceutical quality assurance/control experience (equivalent to a minimum of 8 years experience), including audit, batch record review, change control, complaint handling and investigations experience *Must have demonstrated leadership and people management proficiencies *Must have proven strategic thinking and contingency planning skills *Must have thorough knowledge of pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements (US and EU, particularly) *Must have demonstrated understanding of the processes and interactions essential for ensuring and maintaining regulatory compliance

2. Duties and Responsibilities

Include, but are not limited to, the following:

For the assigned area of the Global Quality and Compliance and International Quality Operations:

*Act as Qualified Person / Responsible Person as per requirements of licences and execute Qualified Person functions in accordance with Professional Code of Conduct of the Joint Professional Bodies *Interpret international, regional, and local regulations and apply those regulations within the GMP/GDP environment *Interact with executive level employees at third party contractors *Participate in GMP- or GDP-related health authority inspections and ensure implementation of corrective actions *Manage quality and compliance risks by conducting risk assessments and ensuring risk mitigation actions are taken *Conduct final review and approval of non-routine quality investigations related to batch deviations, batch disposition, validation activities, stability results, critical quality complaints, and other quality systems for assigned products *Represent Global Quality and Compliance on commercial launch teams for assigned products *Identify and recommend product and process quality improvements *Provide metrics and review monthly trending of Deviations, CAPA, Complaints, etc. for assigned products

This is an exciting opportunity for a long term contract with a global organsation. If you are interested in hearing more about this oportunity and for a full job specification please contact Hemish Ilangaratne on 020 7758 7322 or email immediately.

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