Associate Director, Responsible Person import (RPi)

£90000 - £100000 per annum
  1. Permanent
  2. Senior/Director & VP
  3. United Kingdom
Uxbridge, England
Posting date: 22 Feb 2023
51987

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Proclinical are recruiting an Associate Director, Responsible Person import (RPi) for a biotech organisation. This role is on a permanent basis and is located in Uxbridge. The client is focused on creating, producing and commercialising transformative remedies for those suffering from serious illnesses.


Responsibilities:

  • You will train the associate staff in product quality SOPs and procedures.
  • Manage quality oversight and evaluation of delivery actions, which involves physician samples, as well as promotional resources that have the possibility of influencing product quality or patient safety.
  • Guarantee that a self-inspection program is in place and inspections are carried out at suitable routine intervals.
  • Verify that every single batch imported into Great Britain (GB) is EU-QP certified.
  • Communicate new policies and legal needs issued by the local health authority to the Affiliate Lead Team and appropriate shareholders.
  • Support the Quality Leader in the resolution of product quality related concerns.
  • Other duties may be assigned to this role.

Key Skills and Requirements:

  • Educated to a degree level in a scientific or similar field.
  • Past involvement in a responsible person and responsible perform for import role.
  • At least 5 years of experience within the implementation of FDP guidelines.
  • Know-how of the crucial requisites of products traded under the WDA (H) as well as the home office controlled drug license.
  • Expertise on the position of the MHRA & HPRA within the licensing of remedies.
  • Know-how of pertinent UK, IE & EU legislation.
  • Communication skills both verbally and in writing.
  • Interpersonal and deliberation abilities.
  • A high attention to detail.
  • Willing to travel for business needs up to 10% of the time.

If you are having difficulty in applying or if you have any questions, please contact Josh Godden on +44 203 854 0101.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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