Qualified Person

4 days ago

London Heathrow Airport, United Kingdom CY Partners Full time

Qualified Person (QP)

South 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 global pharmaceutical company that’s significantly scaling it’s operations within the UK?

The Role of Qualified Person (QP)

The company has major growth ambitions and as the Qualified Person you will play a key role in supporting the expansion in the UK and overseas.

As the Qualified Person you will:

- Perform the legal and routine duties of a QP with respect to the review, approval and certification of the company as defined Directive 2001/83/EC and described in Annex 16 of the EU Guide to GMP
- You will act as GMP Subject Matter Expert (SME) to facilitate compliance with the company’s Quality Management system.
- Lead and manage the QP/ Release group, including contracted QPs, Trainee QPs, and other releasing officers
- Ensure systems are identified and in place to maintain compliance with current established GxP standards.
- Support senior QA leadership through QP decision making to drive continuous improvement and compliance.

To be considered for the role of Qualified Person, you’ll need the following skills and experience:

- A degree in Pharmacy, Chemistry or related and/or significant experience in a regulated pharmaceutical function.
- Eligible to act as a Qualified Person in accordance with Human Medicine Regulation 2012 / European Directives 2001/83/EC as amended and meet all the relevant qualification requirements stipulated
- Experience working with oral solid dosage forms, including capsules and tablet formulations and / or non-sterile liquids and suspension
- Proven track record in the management and hands on hosting of Regulatory Inspections by international regulatory bodies. Involvement in internal, customer, regulatory inspections/audits as required
- Experience of hosting MHRA GMDP Inspections
- 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 company, with projected significant growth for the company and the post-holder. The company are offering a fantastic package in an exciting and dynamic environment, withopportunities to develop moving forward as they continue on their ambitious growth plan. In addition, the role may perhaps suit a newly qualified QP looking for the nest step in their career.

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

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