Description
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 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.
- To liaise with customer services to ensure invoices are raised promptly
- Assist the Director of Quality to maintain the audit schedule for pharmaceutical products from outside the EU.
- To liaise with key clients when necessary and, as appropriate host client audits to ensure continued successful business relationships.
- To support the Director of Quality in interactions with UK and International regulatory bodies, taking an active part in hosting inspections.
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 /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
This is an urgent requirement, please contact me as soon as possible if you would be interested in applying for this position.
To find out more about Real please visit www.realstaffing.com