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Qualified Person (QP)

Qualified Person (QP)

  • Location

    Swindon, United Kingdom

  • Sector:

    Quality & Validation

  • Job type:

    Permanent

  • Salary:

    up to £1000,000

  • Contact:

    Joe Lane

  • Contact email:

    joe.lane@catalystcareers.com

  • Job ref:

    58842

  • Published:

    about 2 months ago

  • Expiry date:

    2020-08-09

  • Consultant:

    #

Vacancy Details

My client, based in Wiltshire are looking for Lead QP to join a fast growing business with 4 sites across the UK and still expanding. Its a great opportunity for someone with energy and passion to join a business at senior level and have real influence and input in strategy.

A great chance to be involved with a business that deals with clinical and commercial release and to be involved with business development.

Title: Lead QP

Salary: Competitive

Location: Wiltshire

Responsibilities:

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

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

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

• To provide advice and guidance to staff and customers regarding pharma regulations.

• To provide technical and quality input to projects related to products, facilities and equipment.

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

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

• To provide input and assistance with relevant elements of the Quality management System within the business.

• To provide assistance with regulatory inspections and client audits.

NOT OF INTEREST TO YOU BUT KNOW SOMEONE IT WOULD BE?

Catalyst Life Sciences offer a generous referral scheme reward, whereby anyone who refers us to a successfully placed candidate is entitled to up to £250 worth of vouchers.