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Job Details

Director of Quality Assurance Qualified Person - Pharma

Company: Barrington James Clinical
Reference: CRBG---QAQP
Closing Date: 17 Oct 18
Type: Permanent
Salary (£): Competitive

Job Summary:

This opportunity presents a unique challenge to leverage the well-established heritage of these drugs while simultaneously building a new, unique culture focused on growth, profitability, and long-term vision. What you can expect from this role is the opportunity to work in a start-up type environment where your position will be broad, communication between departments is fast and effective and you will have significant responsibility and autonomy for your work and contribution


Main Responsibilities:

• Importation and market release of commercial medicinal products to the EU markets
• Maintain the Manufacturing and Importation Authorization issued by the Dutch Health Authorities, thereby operating a functional and inspection-ready Quality System
• Host Health Authorities’ inspections at the site
• Perform the necessary controls to import into the EU and release to the market commercial medicinal products thereby issuing the EU batch certification.

Maintain Quality Agreements with the following parties:
o Swiss Headquarters for the oversight of GMP production at the various contract manufacturing organizations.
o EU based 3PLs for the storage and distribution of medicinal products
o EU based contract laboratories for the importation testing of medicinal products

Maintain a functional system which includes:
o Product complaints
o Recall of defective medicinal products from the EU market
o Product Quality Review Reports
o Variation of marketing authorizations through change control
o Quality risk management
o Reference and Retention Samples
o Outsourced activities
o Certification and Batch Release
o QP Declaration procedures for APIs
• Write/review/approve, as applicable, the various company policies and standard operating procedures

Required Background and Skills:

• Degree in Pharmacy (at least four years)
• A minimum of 10 years’ experience in pharma/biotech industry as Qualified Person
• Previous experience with set up of Quality Systems is critical
• Dutch and English must be very fluent or native

Apply for this job: Director of Quality Assurance Qualified Person - Pharma

Contact Information:

Address:  Head Office
Victoria House Consort Way Horley Surrey
Tel:  01293 776644
Fax:  01293 822333
Website:  Visit Our Web Site

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