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.
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 email@example.com