Qualified Person

Location Wiltshire
Discipline: Renewable Energy, Defence, Executive Recruitment
Job type: Permanent
Salary: ££65k
Contact name: Carrie MacDonald

Contact email: carrie@requireconsultancy.com
Job ref: REF: 6679
Published: about 2 months ago
Expiry date: 01 May 2021

At ReQuire Consultancy, we are delighted to be partnering with a leading Biopharmaceuticals organisation in Salisbury who are looking to appoint a Qualified Person to join their QP group.

In this role you will have key working relationships with national and international scientific experts across private and public sectors, as well as a broad range of internal and external stakeholders.

Main responsibilities include:

  • Review batch manufacturing documentation to ensure compliance with EU GMP and the Product Specification File/marketing authorisation (or other where relevant)

  • Certify Medicinal products for use in the EU and outside the EU (where relevant)

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

  • Provide advice and guidance to PBL staff and customers regarding pharma regulations.

  • Provide technical and quality input to PBL projects related to products, facilities and equipment.

  • Keep up to date with the requirements of the Medicines Authorities across the EU and rest of the world (where relevant).

  • Review company project files (PSFs, commercial project files etc) to ensure compliance with the current regulatory requirements and PBL procedures.

  • Provide input and assistance with relevant elements of the Quality management System (QMS) within the business.

  • Assist with regulatory inspections and client audits.

  • Promote and uphold the highest standards of professionalism in order to create, maintain and enhance the reputation of the business amongst its customers and stakeholders both nationally and internationally.

  • 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 PBL compliance.

Person Specification:

  • Have current right to work in the UK

  • Eligible QP as per directive 2001/83/EU

  • Extensive QA experience within the medicinal products/pharmaceutical industry

  • Experience in sterile manufacture or biopharmaceuticals (desirable)

  • Strong leadership qualities including inspiring change, achieving results, collaborating working and personal improvement.

  • Programme and project management experience

  • Excellent corporate awareness

This position will require you to travel and represent the business overseas.

For more information please contact Carrie on 01722 741840 or email carrie@requireconsultancy.com