Qualified Person

RBW Consulting; Manchester; On-site; GBP 70,000 - 110,000; Full time

Benefits offered by this job

Competitive salary and annual bonus

Professional development and ongoing培训

Job summary

RBW Consulting is seeking a Qualified Person (QP) for an aseptic pharmaceutical site in Manchester. The role certifies and releases batches in line with EU/UK GMP, ensuring aseptic compliance and providing leadership to cross‑functional teams.

The successful candidate must be eligible to act as a QP under UK/EU Directive 2001/83/EC, have aseptic manufacturing experience, and solid MHRA/EMA knowledge. On‑site, full‑time with occasional early shifts.

Qualifications

• 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

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

Decision-making

Problem-solving

Communication skills

Job description

Qualified Person (QP) – Aseptic Pharmaceuticals

Location: Manchester (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