Qualified Person (QP)

Job Role: Qualified Person (QP)

Job Type: Full-time permanent position

Location: East London/Essex, UK – 4x a week on site, 1-day WFH

Remuneration: Up to £90,000 + 10% Bonus + Car Allowance

My client is a leading European specialty pharmaceutical company that is seeking an experienced Qualified Person. This pivotal role involves supporting the batch release of products manufactured on the business's site and driving a quality culture across the organisation.

Requiring an experienced QP to join the team with prior experience working on site as a Qualified Person and ideally working on sterile and non-sterile products.  

Key Responsibilities:

·      Oversee batch release processes to ensure compliance with regulatory standards. Provide QA support to manufacturing, packaging and supply chain, and to all business areas.

·      Provide advice, guidance, support and mentoring to all staff with the site in matters relating to the safety, quality and efficacy of the manufacturing and distribution of medicinal products and investigational medical products.

·      Review, assess and management of quality risk.

·      Collaborate with cross-functional teams to maintain high-quality standards.

·      Implement and promote a strong quality culture within the organization.

·      To ensure product is made in accordance with manufacturing licenses and equivalent marketing authorizations.

·      Assure product, process and facilities comply with national and global regulatory requirements in alignment to the site policies.

·      Provide quality oversight of all activities on site and of subcontractors.

·      To actively participate in/chair Site Quality Review Team Meetings.

·      To ensure any significant quality or compliance issues are escalated to senior management.

·      To review and approve quality documentation.

Qualifications:

·      Proven experience as a Qualified Person (Minimum 2 years as a QP) in the pharmaceutical industry.

·      In-depth knowledge of regulatory requirements and quality assurance.

·      Strong analytical and problem-solving skills.

·      Registered UK/EU Qualified person with relevant experience in the pharmaceutical industry.

·      Passionate leader able to drive a culture with Quality at the centre of decision making.

·      Enjoy a fast-paced environment and autonomy.

·      Strong GMP background and related decision-making skills.

·      Experience working with solid dosage forms including tablet formations, capsules and non-sterile liquids and suspensions.

·      Extensive QMS management experience.

·      Previous experience working on-site as a QP.

This role does not offer Sponsorship, so you MUST hold the full right to work in the UK.

This role is 4x a week on site in Essex.

For more information please contact lucy.kirkaldy@cpl.com