Development QA Specialist

About The Role

Bespak are looking for a Development QA Specialist for a permanent position for this onsite role at the Holmes Chapel site, CW4 8BE
. The salary for this role is £43500 - £51500. Other benefits you will receive are 25 days annual leave plus bank holidays, discretionary annual bonus, generous 10% pension contribution, onsite free parking, and medical / dental / health / life assurance.

Monday to Friday usual working times of 8:30am to 5:00pm with an 8:30am to 3:45pm finish on a Friday. There is some flexibility on start and finish times.

Once you click apply, you will be redirected to our company website to make your application.

As a Development QA Specialist, you will contribute to customer-funded drug product development projects within the Drug Product Development Team. You will ensure full compliance with Quality Assurance principles, cGMP standards, and current regulatory guidance for combination and inhaled products.

In this role, you will provide expert QA and compliance support for commercial manufacturing and new product industrialisation, promote a strong quality culture through training and coaching, and apply risk management principles to safeguard product quality, patient safety, and efficacy.

This is an exciting opportunity to play a pivotal role in bringing innovative medicines to patients while shaping quality excellence across development and commercialisation.

Bespak in Holmes Chapel is an Investors in People Silver Award-winning pharmaceutical CDMO with over 350 employees, currently going through a period of significant site expansion.

We are investing heavily to increase our capacity for developing and manufacturing sustainable pMDIs with greener propellants, meeting evolving industry standards, while providing comprehensive development, manufacturing, filling, and finishing solutions for a range of medical devices, including SMIs, DPIs, nasal sprays.

• Provide quality oversight for new product development, including design, commissioning, qualification, and validation activities.
• Support and lead customer projects to ensure successful clinical delivery and commercial readiness.
• Drive Quality Management System activities, including deviations, OOS investigations, CAPA, change control, risk assessments, and validation approval.
• Ensure timely review and release of development documentation to meet customer milestones.
• Lead or support root cause investigations and resolution of critical quality issues.
• Conduct internal audits and support regulatory and customer inspections.
• Promote continuous improvement, compliance excellence, and a strong quality culture across Drug Product Development.
• Lead QA support across Manufacturing, Production, and QC, including batch disposition, documentation approval, deviations, investigations, and CAPA.
• Partner with cross-functional and project teams to deliver risk-based quality guidance and support non‑standard activities.
• Lead inspection readiness activities and support internal, customer, and regulatory inspections.
• Drive continuous improvement through Product Quality Reviews, monitoring of quality metrics, and development of site quality systems.

• Degree qualified (or equivalent experience) with 3+ years’ experience in Pharmaceutical Quality (5+ years preferred), ideally within an R&D or development environment.
• Strong working knowledge of cGMP and application of Quality Management Systems in a regulated setting.
• Experience managing deviations, investigations, CAPA, change control, and risk assessments using a risk-based approach.
• Good understanding of qualification/validation of facilities, utilities, equipment, processes, cleaning, computerised systems, and new product introduction (lab and/or manufacturing).
• Proven troubleshooting and problem-solving capability within development or project environments.
• Experience with inhaled combination products is desirable.
• Strong communication, interpersonal, and stakeholder management skills, with the ability to produce clear technical documentation and reports.
• Highly organised, detail-oriented, self-motivated, and confident managing…