Qualified Person (QP)

This is an exceptional opportunity for a highly motivated individual to contribute to the continued success and growth of our client organization.

As a Qualified Person (QP) the successful candidate will play a key role in driving compliance with MHRA Regulatory and Company standards.

The Qualified Person will play a critical role in certifying and releasing investigational medicinal product batches, as well as approving shelf-life extensions in accordance with regulatory guidelines. Close collaboration with QA Operations will be essential in ensuring seamless operations. Additionally, the successful candidate will review and endorse various quality system documents such as artwork, procedures, validation reports, and change controls. Supporting regulatory submissions and managing Product Specification will be among their key responsibilities, along with leading audits and inspections. The Qualified Person will actively participate in meetings, liaise with stakeholders as needed, and contribute to change control and Corrective and Preventive Action (CAPA) review boards to uphold quality standards and regulatory compliance.

Qualification and Experience

• BSc, MSc, or PhD in Life Sciences or related disciplines.
• 5+ years of pharmaceutical industry experience.
• Eligible to act as a Qualified Person under Directive 75/319/EC (2001/83/EC).
• Proven track record in managing and hosting Regulatory Inspections conducted by international regulatory bodies.
• Experience in internal and external auditing, validation, and operational support in a QA role.
• Proficiency in the application of Quality Risk Management tools.
• Proficiency in compliance with regulatory standards and the ability to effectively navigate inspection processes.

Skills and Attributes:

Strong communication, planning, and organizational skills.

Effective management abilities.

Strategic thinking and problem-solving skills.

Self-motivated and collaborative.

Methodical and detail-oriented

Only candidates living in the UK with eligibility to work will be considered for this position.

Skills: QP, cGMP experience, ICH guidelines awareness, regulatory, validation.

approval for Manufacturing Order Confirmations, quality issues within operations.