Qualified Person- Contract- Pharma

My client is a large CMO looking for a Qualified Person on an interim basis. This will initially be a 6 months contract and will potentially carry on for a furthre 6 months.

The key Qualifications / Skills and Experience required are:
* A minimum of a first degree in Pharmacy, Chemistry or a Life Science OR significant experience (e.g.>10 years) in a regulated pharmaceutical function.

* Eligible to act as a Qualified Person under Directive 2001/83/EC.

* A minimum of 5 years' experience in a pharmaceutical Quality environment, and previous experience as a certifying QP preferable. Operational experience within a Pharmaceutical manufacturing or laboratory setting is desirable.

* Experience in Clinical Trials / Sterile / or Potent manufacture would be desirable

* Proficient in project management tools, with a proven ability to operate in an international company within a pre-defined timeframe.

* Excellent communication skills both verbal and written are required in this role and people management skills would be beneficial.

* Proven track record in the management and hands on hosting of Regulatory Inspections by international regulatory bodies

The Key Responsibilities of the Qualified Person will be:
* Act as a named operational Qualified Person under the site manufacturing authorisations, and organise the certification of commercial and investigational medicinal pharmaceutical product. To maintain a register of all products certified.
* To maintain client contact to ensure all information and documents are available to allow release to occur.
* Devise, review, implement and manage systems within the group, including communication and information management, to achieve continuous process improvement.
* To liaise with Business Development in the preparation of proposals requiring QP input.

For more information please call 0207 758 7322 or email

To find out more about Real Staffing please visit www.realstaffing.com