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Qualified Person

Posted 9 March by RHL Easy Apply Ended

An exciting opportunity has emerged to work for a rapidly expanding, biopharmaceutical company who produce lifesaving products.

Are you a QP looking for your next challenge? Our client are looking for a Qualified Person who will be accountable to the Quality Director for the delivery of autonomous and innovative Quality Management. The department performs the manufacture of two licensed biopharmaceuticals as well as contract manufacturing and development projects.

Job Title: Head Qualified Person

Reference No: 238585

Location: Wiltshire
Job Type: Permanent
Salary: Commensurate with experience

Job responsibilities:

  • Manage the GP group for the release of safe and efficacious products produced to the required Quality standard.

  • Develop a positive relationship with regulatory authorities to ensure compliance with the MAA and cGMP.

  • Provide oversight and development for Quality Systems (including GxP).

  • Deliver continuous improvement in all areas of the business to enhance the quality, delivery, rate of growth and competitiveness.

  • Liaise and interact positively with appropriate regulatory authorities to ensure Company compliance with the MAA and cGMP.

  • Lead and manage a team of QPs responsible for certification and release of licenced medicinal products and investigational medicinal products.

  • Ensure the timely review of all Batch Manufacturing Documents in accordance with manufacturing schedules and product delivery dates.

  • To undertake audits in EU and third countries to ensure that sponsor manufacturing sites are operating in general compliance with EU GMP.

  • Coach and mentor the Company staff to improve problem solving and early problem resolution.

Person specification

  • Accredited GP

  • Extensive experience within the medicinal products / pharmaceutical industry

  • Experience in sterile manufacture

  • Experience in biopharmaceuticals

  • Willingness to travel and represent the business overseas

  • Programme and project management

Please apply to Danni Arnold, Consultant; ;

RHL is a specialist Recruitment Consultancy within Life Science talent acquisition.

Recruitment Holdings Ltd (RHL) acts as an Employment Business and as an Employment Agency.

Required skills

  • Biologics
  • Biotechnology
  • Compliance
  • GMP
  • cGMP
  • Quality
  • QP
  • Qualified Person
  • Sterile
  • Aspetic

Reference: 34647253

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