Qualified Person

4 months ago

Tredegar, United Kingdom Yolk Recruitment Full time

**Qualified Person / QP**

**Up to £100,000 doe**

**Flexible Working**

Join a leading pharmaceutical company and make a real impact on the healthcare industry as a Qualified Person (QP) At Yolk, we are excited to support this Global Company in their search for a highly skilled and experienced QP with IMP and commercial expertise. As a QP, you will play a crucial role in ensuring the quality and compliance of licensed and investigational products, overseeing manufacturing and testing activities while adhering to UK and EU regulatory requirements.

**This is what you'll be doing as QP**:

- Carry out the duties of a Qualified Person as defined in the Human regulations 2012 and Medicines for Human Use (Clinical Trials) regulation 2004, and EU guide to cGMP.
- Release batches according to standard procedures, ensuring compliance with relevant regulations and directives.
- Assess deviations and take appropriate actions to maintain product quality.
- Provide resources for the certification of batches, preparing them for market release.
- Stay up-to-date with current and forthcoming legislation impacting pharmaceutical product manufacturing.
- Maintain an understanding of current product license requirements to ensure compliance.
- Develop proposals for efficiency savings in the release process, contributing to process improvement.
- Act as a point of leadership, supporting staff by discussing product quality issues, providing education, and technical input.

***

**The experience you'll bring to the team as QP**:

- Extensive experience in releasing Investigational Medicinal Products (IMPs), including biologics and sterile products.
- Experience in ATMP's and Cell and gene therapy would be advantageous.
- Possess extensive knowledge of current Good Manufacturing Practice (GMP), Good Distribution Practice (GDP), and Good Clinical Practice (GCP).
- Experience in auditing GMP/GDP/GCP/ISO environments, and familiarity with regulatory and ISO inspections.
- Understanding of global guidelines for the manufacture of pharmaceutical products.

***

**And this is what you'll get in return**:

- Highly competitive salary based on your qualifications and experience.
- Annual Bonus
- Generous benefits package
- Opportunity to work with a reputable company that values professional growth and development.
- Chance to make a significant impact on the healthcare industry and improve patients' lives.

**Are you up to the challenge?

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