Technical Director - QP

Recruiter
Clinitemp Ltd
Location
Crawley, West Sussex, RH10
Salary
£80,000 per annum
Posted
03 Feb 2019
Closes
17 Feb 2019
Contract Type
Permanent
Language
English

Clinitemp Ltd are currently recruiting a Technical Director / QP.

Our client is a Global organisation with a presence in over 40 countries, rapidly expanding, with eight manufacturing plants under it's name currently. The organisation specialises in the manufacture of generic medicines, established on the principles of providing cost effective prescriptive medicines without compromise on quality.

Responsibilities: Reporting to the Managing Director of UK operations, you will be responsible for the overall management of the regulatory affairs, quality and pharmaco vigilance teams, ensuring streamline and direct communications with manufacturing organisations and be the qualified person to release batches to the EU.

Other Responsibilities Include:

  • To identify and report key milestone status in all product launches.
  • Responsible for department budgets ensuring there is no overspend.
  • Responsible for the overall manufacturing strategy and technology transfer.
  • To train, develop and mentor the Technical Operations team.
  • To ensure full complaince at all times to meet the expectation of the Health Research Authority.
  • Understanding of European regulatory guidelines, regulations and procedures.
  • Experience in manufacturing and technology transfer of oral solids to CMOs
  • Knowledge of GMP and GDP.
  • Knowledge of Regulatory Affairs esp MHRA .
  • Experience of managing a multi-cultural team.
  • Understanding of the time-scales of the approval processes within the MHRA.
  • Qualified Person for EU Batch Release.
  • Understanding of pharmaco vigilance practices and procedures.
  • Understanding of the drug development and manufacturing process.
  • Ability to manage conflicting priorities.
  • Excellent communication and strategic planning skills.
  • Commercial Outlook
  • Strong interpersonal skills
  • Accurate
  • Methodical
  • Attention to detail
  • Proactive
    Please only apply if you are a QP