Qualified Person (QP)

JR United Kingdom; Belfast; On-site; GBP 70,000 - 90,000; Full time

Job summary

A leading European specialty pharmaceutical company seeks a Qualified Person to oversee batch releases and enhance quality culture. Ideal candidates will have over two years of experience in regulatory compliance and quality assurance in the pharma sector, driving quality in a fast-paced environment.

Qualifications

• Minimum 2 years experience as a Qualified Person in pharmaceutical.
• Strong GMP background and solid dosage forms experience.
• In-depth knowledge of regulatory requirements.

Responsibilities

• Oversee batch release processes ensuring compliance with regulatory standards.
• Provide quality oversight of onsite activities and subcontractors.
• Implement and promote a strong quality culture within the organization.

Skills

Analytical skills

Problem-solving skills

Leadership

GMP knowledge

Education

Registration as UK/EU Qualified Person

Job description

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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.
• Previous experience working on-site as a QP.

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

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