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Job Details

Qualified Person

Company: Clinical Professionals Ltd
Location: Hertfordshire
Reference: J30440
Closing Date: 20 Dec 17
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

Qualified Person Hertfordshire Working with this leading Pharmaceutical business, you will be at the front end of an exciting and transformational time in the company.

Requirements:

Qualified Person
Hertfordshire

Working with this leading Pharmaceutical business, you will be at the front end of an exciting and transformational time in the company. We seek dynamic and proactive individuals to support the business as it develops and grows in this exciting time.

The Qualified Person position falls within the Quality Unit, whose primary accountability is to ensure that all GMP activities at manufacturing facilities (together with any 3rd Parties) are compliant, in addition to providing quality assurance expertise to both the sales and development divisions. The role is required to act in compliance with the legal responsibilities and routine duties of the Qualified Person as defined by EU Directives and Local Law.

Key Responsibilities:

* To act as a Qualified Person in accordance with EU GMP to provide final certification/release.
* To coordinate (with Asia and Europe) the timely release of product for European supply for all products.
* To review and approve change control request from manufacturing sites in compliance with marketing authorisations.
* To ensuring suitable contracts and technical agreements are prepared and implemented between client and contractors.
* To provide QP GMP declarations in support of importation activities on Marketing Authorisations.
* To provide Quality Assurance support and to ensure a state of compliance
* To perform audits of manufacturing and third party providers in order to ensure EU GMP standards
* To perform internal audits to enable permanent inspection readiness

External Interfaces

* MHRA, IMB, SUKL, EMA and other EU and Non EU Regulatory Authorities.
* Third Parties - Nordic, Netherlands

Knowledge, Skills, and abilities

* Qualified Person 2001/83/EC
* Chemistry or Pharmacy degree supported by appropriate post graduate qualification.
* Previous experience as a QP, human, IMP
* Wide experience of a Quality role in a pharmaceutical company
* Auditing experience -GMP/ICHQ7A/ISO9000/PS9000
* Membership of appropriate professional society, e.g. Royal Society of Chemistry, Society of Biology, Royal Pharmaceutical Society of Great Britain.

Apply for this job: Qualified Person

Contact Information:

Address:  Clinical Professionals UK
3rd Floor
33 Blagrave Street
Reading
Berkshire
RG1 1PW
England
Tel:  0044 118 959 4990
Fax:  0044 118 956 0607
Website:  Visit Our Web Site

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