personal assistant Tredegar, Wales
Job description
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?
If you have the expertise and passion to take on this crucial role as a Qualified Person (QP), we want to hear from you! Apply now and be part of a dynamic team dedicated to delivering high-quality pharmaceutical products. Join us at Yolk and seize this exciting opportunity to advance your career in the pharmaceutical sector.
- Please note, whilst we do our best to contact all candidates, due to the high number of applications we receive we cannot guarantee this for every role. If you have not heard anything from us within 7 days of applying - then unfortunately you have been unsuccessful. Please keep an eye on our website for more opportunities.
