Qualified Person (QP)

JR United Kingdom; Coventry; On-site; GBP 80,000 - 90,000; Full time

Job summary

A leading European specialty pharmaceutical company seeks an experienced Qualified Person to oversee batch releases and enhance quality culture. The role requires a QP with a minimum of 2 years in the pharmaceutical industry, strong leadership skills, and compliance expertise. This full-time position offers competitive remuneration including a bonus and car allowance, and demands full rights to work in the UK. The role is primarily based in Essex with four days on-site.

Qualifications

• Minimum 2 years as a QP in the pharmaceutical industry.
• Knowledge of regulatory requirements and quality assurance.
• Experience working with solid dosage forms.

Responsibilities

• Oversee batch release processes ensuring compliance with standards.
• Collaborate with cross-functional teams to maintain quality.
• Provide quality oversight of all activities on site.

Skills

Analytical skills

Problem-solving

Leadership

Quality assurance knowledge

Strong GMP background

Education

Registered UK/EU Qualified Person

Job description

Social network you want to login/join with:

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.