Qualified Person (QP) - Sterile Manufacturing

JR United Kingdom; London; On-site; GBP 50,000 - 80,000; Full time

Job summary

An established industry player is seeking a Qualified Person to enhance their Quality Management System in London. This pivotal role involves ensuring compliance with cGMP regulations, overseeing batch release activities, and collaborating with stakeholders to maintain high-quality standards. The ideal candidate will possess a strong background in Life Sciences and relevant qualifications, making a significant impact on the pharmaceutical sector. Join a forward-thinking company that values quality and compliance, and contribute to the development of groundbreaking clinical trial products.

Qualifications

• Qualified Person (QP) qualification under Directive 2001/20/EC and 2001/83/EC.
• Strong knowledge of cGMP, MHRA and EU guidelines.

Responsibilities

• Develop and improve the QMS & Compliance strategy for cGMP regulations.
• Carry out QP batch release of clinical trial products.

Skills

Quality Assurance

cGMP

Regulatory Standards

Mentoring

Education

BSc/MSc in Life Sciences

Tools

eQMS

PQS

Job description

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Qualified Person (QP) - Sterile Manufacturing, london

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Client:

Walker Cole International

Location:

london, United Kingdom

Job Category:

Other

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EU work permit required:

Yes

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Job Views:

3

Posted:

05.05.2025

Expiry Date:

19.06.2025

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Job Description:

Walker Cole International is searching for a Qualified Person to join a Pharmaceutical company based in London. As the Qualified Person you will be a key part of ensuring maintenance of the company's QMS and performing batch release activities.

You will be responsible for:

• Developing, maintaining and improving the QMS & Compliance strategy to ensure they meet cGMP regulations and regulatory standards.
• Carrying out the QP batch release of a range of clinical trial products.
• Collaborating with both internal and external stakeholders to have an oversight of all clinical QA functions and activities.
• Mentoring and assisting junior members of staff with their own development and training

The successful candidate will have:

• A BSc/MSc (or equivalent) in a Life Sciences discipline.
• Qualified Person (QP) qualification under the provision of the Directive 2001/20/EC and 2001/83/EC.
• Strong knowledge of cGMP, MHRA and EU guidelines.

Quality Assurance | QA | Qualified Person | Pharmaceutical | CAPA | Corrective and Preventative Action | Quality | eQMS | PQS | Pharmaceutical Quality System | Batch Release | QP | GMP | Good Manufacturing Practice | QMS | Quality Management System | Operational | IMP | Investigational Medicinal Product | Commercial | GCP | Clinical