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Job Details

Qualified Person

Company: GW Pharmaceuticals
Location:
Reference: QP-Ph
Closing Date: 20 Apr 17
Type: Full Time
Salary (£): Competitive
Benefits:

Top Job

Job Summary:

GW is now looking to recruit a full time permanent Qualified Person.

Requirements:

Location: South East


 The role

Certify by completion of the QP register - prior to the release for sale, placing on the market, or export - that each batch of medicinal product and/or Active Pharmaceutical Ingredient (API) has been manufactured to cGMP and checked in compliance with the laws of that member state and in accordance with the requirements of the marketing authorisation, GW Technical Agreements (GW Partners/Contract Manufacturing Organisations), and GW expectations.


 KEY RESPONSIBILITIES

• Review of batch documentation for pharmaceutical products/API and complete subsequent batch disposition, including certification for release, confirming in accordance with Annex 16 that the batch and its manufacture comply with the provisions of the marketing authorisation.

• Verify all necessary production and QC documentation has been completed and endorsed by the staff authorised to do so. Ensuring that all necessary checks and tests have been performed, including any additional sampling, inspection, tests or checks initiated because of deviations, Out-of-Specification investigations, or planned changes.

• Ensure that products/API have been manufactured according to cGMP, including those from Contract Manufacturing Organisations (CMO). If products are imported from a third country, that they are manufactured according to standards at least equivalent to EU GMP. Confirm that all related manufacturing and testing processes have been validated.

• Ensure Deviations or planned changes in production or QC have been authorised by the persons responsible in accordance with a defined system.

• Ensure released batches subject to variations to market are released within the correct parameters during that process (e.g. artwork updates).

• Products manufactured within EU – the QP must ensure that each batch was produced and tested according to GMP and Licensed conditions.

• Products manufactured outside the EU – the QP must ensure that each imported batch has undergone re-testing and evaluation.


KEY ATTRIBUTES - ESSENTIAL


Knowledge:
• Eligibility to act as a Qualified Person
• Proven experience in the Pharmaceutical Industry in a QP capacity
• Degree in relevant scientific field
• Scientific body membership
• Recent and relevant experience of working with regulatory bodies


Skills:

• Proficiency in speaking, comprehending, reading and writing English is required
• Ensure adherence to QP guidelines, code of conduct, and maintenance of CPD
• High level of numeracy
• Excellent attention to detail

Location: South East 
To apply please send your CV with salary expectations to recruitment@gwpharm.com with the reference QP-Ph

Apply for this job: Qualified Person

Contact Information:

Address:  Head Office
Sovereign House Vision Park Chivers Way Histon Cambridge
CB24 9BZ
England
Tel:  01223266800
Website:  Visit Our Web Site

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