Qualified Person

Qualified Person

Biotechnology

Location Durham

Salary up to £95,000 plus benefits

Contract Permanent

Reference CYQPH39

Date Posted

Consultant

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Qualified Person (QP)

North East based with option for hybrid working
Competitive Salary + Bonus + Benefits

Are you eligible to act as a Qualified Person?

Would you like to work for a leading pharmaceutical CDMO company that is investing significantly in their site in the North East?

The Role of Qualified Person (QP)

As the Qualified Person you will:
• Certify batches in accordance with EU Directive 2001/83/EC, 2001/82/ EC, 2001/20/EC and Regulation 536/2014 as required, and in accordance with the Code of Practice for Qualified Persons.
• Act as a GMP Subject Matter Expert to facilitate and ensure site compliance with the company’s Pharmaceutical Quality System (PQS) through:
o Providing expertise and guidance on application of cGMP to customers – both generally and in specific, product-related situations.
o Driving risk based continuous improvement of the site PQS through review of data and action recommendation to Site Leadership Team (Management Review)
• To support the site leadership team through QP decision making to drive continuous improvement of the site Pharmaceutical Quality Management System (PQMS).

To be considered for the role of Qualified Person, you’ll need the following skills and experience:
• A degree in Chemistry or related and/or significant experience in a regulated pharmaceutical function.
• Eligible to act as a Qualified Person under EU directives 2001/83/EC, 2001/82/EC and 2001/20/EC and Regulation 536/2014 with at demonstrable experience of being active on a Licence. • Experience of working with and influencing senior management and customers.
• Excellent knowledge of the principles and practices of cGMP and understanding of their application in the manufacture of Biologic Drug Substances.
• You will be resilient and calm under pressure, with strong people skills and a proven ability to influence people to achieve objectives and drive performance. You will have a strong continuous improvement mindset.

This is an exceptional role for someone who is looking to take a step into a dynamic organisation, with projected significant growth for the company and the post-holder. The company are offering a fantastic package in an exciting and dynamic environment, with opportunities to develop moving forward as they continue on their ambitious growth plan.

Location – The role is to be primarily based at the site in the North East of England, but please note that there is opportunity to combine on and offsite working.

Application Instructions:
Please apply online here –

Alternatively, please contact Dan Younger at CY Partners on 07501 723 352 or [email protected] for further information

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Qualified Person

Biotechnology

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