Qualified Person

RBW Consulting; Stoke-on-Trent; On-site; GBP 65,000 - 90,000; Full time

Benefits offered by this job

Competitive salary + bonus

Professional development

Quality-driven culture

Job summary

RBW Consulting is seeking a Qualified Person (QP) for an aseptic pharmaceutical site in Stoke-on-Trent. This full-time, site-based role offers the chance to ensure the safety, quality and compliance of sterile medicinal products.

You will certify and release batches in line with EU/UK GMP, support aseptic operations, and lead investigations, audits and regulatory interactions. Some early morning shifts are required.

Qualifications

• Eligibility to act as QP under UK/EU Directive 2001/83/EC.
• Experience in aseptic/sterile manufacturing preferred.
• Strong knowledge of MHRA/EMA requirements and GMP principles.
• Excellent decision-making and problem-solving abilities.
• Strong communication and collaboration in a fast-paced regulated environment.
• Willingness to work on-site full-time with early morning shifts.

Responsibilities

• Certify and release batches of aseptically manufactured products in line with Annex 16 and applicable regulations.
• Ensure ongoing GMP compliance across production, quality systems, and the wider site.
• Provide oversight and support during aseptic operations, media fills, and environmental monitoring activities.
• Lead or support investigations, risk assessments, and deviation/CAPA management.
• Contribute to continuous improvement initiatives and audit readiness.
• Act as a key liaison during regulatory inspections and internal/external audits.
• Offer expert QP advice to cross-functional teams.
• Participate in early morning shifts as required to support aseptic operations.

Skills

QP eligibility

Aseptic manufacturing experience

GMP/MHRA knowledge

Decision making

Communication

On-site availability

Job description

Qualified Person (QP) - Aseptic Pharmaceuticals

Location: Stoke-on-Trent (Site-Based)

Hours: Full-time, with some early morning shifts

Salary: Competitive + excellent benefits package

About the Role

We are looking for an experienced Qualified Person (QP) to join an aseptic pharmaceutical manufacturing site in Stoke-on-Trent. This is an exciting opportunity to play a critical role in ensuring the safety, quality, and compliance of sterile medicinal products manufactured on-site.

As the QP, you will be responsible for the certification and release of batches in accordance with EU/UK GMP requirements. You'll work closely with Quality, Production, Validation, and Regulatory teams, providing leadership and expert guidance to maintain the highest standards of aseptic control.

Key Responsibilities

• Certify and release batches of aseptically manufactured products in line with Annex 16 and applicable regulations
• Ensure ongoing GMP compliance across production, quality systems, and the wider site
• Provide oversight and support during aseptic operations, media fills, and environmental monitoring activities
• Lead or support investigations, risk assessments, and deviation/CAPA management
• Contribute to continuous improvement initiatives and audit readiness
• Act as a key liaison during regulatory inspections and internal/external audits
• Offer expert QP advice to cross-functional teams
• Participate in early morning shifts as required to support aseptic operations

About You

• Eligibility to act as a Qualified Person under UK/EU Directive 2001/83/EC
• Some previous experience within aseptic/sterile manufacturing preferred
• Sound knowledge of MHRA/EMA requirements and GMP principles
• Excellent decision-making, problem-solving, and communication skills
• Collaborative, resilient, and comfortable working in a fast-paced regulated environment
• Able to work on-site full-time and support early morning activities when needed

What's on Offer

• Competitive salary and annual bonus
• Professional development and continuous training
• A supportive, quality-driven culture with opportunities to influence and improve