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For Companies At a Glance
- Tasks: Ensure quality in drug product development and support innovative projects.
- Company: Join Bespak, a leading pharmaceutical company with a strong focus on quality.
- Benefits: Enjoy 25 days holiday, generous pension, private medical insurance, and more.
- Other info: Flexible working hours and a supportive, inclusive environment await you.
- Why this job: Make a real impact in healthcare by ensuring the quality of innovative medicines.
- Qualifications: Degree in a relevant field with experience in Pharmaceutical Quality.
The predicted salary is between 43500 - 51500 £ per year.
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 £43,500 - £51,500. 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.
Working Pattern: 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.
Role Overview
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.
Responsibilities
- 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.
Key Skills and Experience
- 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 multiple priorities.
- Proficient in MS Office (experience with LIMS/ERP systems advantageous).
Benefits
- 25 days annual holiday + bank holidays + Buy/Sell Scheme
- A generous employer pension contribution
- Private medical insurance
- Private dental Insurance
- Permanent Health Insurance
- Group life assurance
- Free will writing service
- Active well-being programme
- Recognition awards
- Free Parking
About Holmes Chapel
Holmes Chapel is a beautiful village in Cheshire with excellent transport links via its railway station on the Crewe-Manchester Line, proximity to the motorway network and Manchester Airport. The National Parks of the Peak District, Lake District and Eryri (Snowdonia) are within easy reach. The village has a population of nearly 7,000 and offers various amenities, including supermarkets, shops, restaurants, schools, and a GP practice.
Values and Ethics
As an ethical employer we align our BZero sustainability initiative to the SBTI certification which means we are on a road to carbon reduction targeting net zero and are proud to be ISO certified in 14001, 45001 and 13485.
Core Values
Our core values are Customer Focussed, Respectful, Collaborative, and Agile, woven into the fabric of our business and the values we measure ourselves by.
Work-Life Balance
We are flexible. We understand that there is a life outside of work, so we aim to support you in attaining a happy work/life balance. To cater for employees’ individual circumstances, and where possible, we agree flexible working arrangements.
Diversity and Inclusion
We value our inclusivity as we believe diversity should be embraced and celebrated. We live and work by these values and that’s what makes our company a great place to work.
Disability Positive Employment
We are proud to be a disability positive employer. We will support you throughout the recruitment process with any adjustments you require therefore please contact the Recruitment Team if you require support.
Data Protection and Recruitment Process
By applying to this role, you are giving consent to Bespak Limited to process your personal data for employment/recruitment purposes only. All personal and sensitive data processed to Bespak is protected under GDPR regulations.
Please be advised that we are working with our trusted recruitment partner, Kinetic PLC, to manage this recruitment process. As such, a consultant from their team may screen your application and contact you directly on our behalf to progress your application.
Development QA Specialist employer: Bespak
Contact Detail:
Bespak Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Development QA Specialist
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work in QA or development roles. A friendly chat can lead to insider info about job openings or even referrals.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of cGMP and Quality Management Systems. Be ready to discuss how you've tackled quality issues in the past and how you can contribute to maintaining compliance at Bespak.
✨Tip Number 3
Showcase your problem-solving skills! During interviews, share specific examples of how you've resolved critical quality issues or led successful investigations. This will demonstrate your capability to handle challenges in the role.
✨Tip Number 4
Don't forget to apply through our website! It’s the best way to ensure your application gets the attention it deserves. Plus, you'll find all the details about the role and benefits right there.
We think you need these skills to ace Development QA Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV is tailored to the Development QA Specialist role. Highlight your experience in pharmaceutical quality and any relevant projects you've worked on. We want to see how your skills align with our needs!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance and how you can contribute to our team. Keep it concise but impactful – we love a good story!
Showcase Your Skills: Don’t forget to showcase your key skills in your application. Mention your knowledge of cGMP, risk management, and any experience with inhaled combination products. We’re looking for someone who can hit the ground running!
Apply Through Our Website: Once you're ready, make sure to apply through our website. It’s the best way to ensure your application gets to us directly. Plus, you’ll find all the details you need about the role there!
How to prepare for a job interview at Bespak
✨Know Your Quality Standards
Make sure you brush up on your knowledge of cGMP and Quality Management Systems. Be ready to discuss how you've applied these principles in past roles, especially in a regulated environment. This will show that you understand the importance of compliance in drug product development.
✨Showcase Your Problem-Solving Skills
Prepare examples of how you've tackled quality issues or deviations in previous projects. Highlight your troubleshooting capabilities and how you’ve led investigations or implemented CAPA. This will demonstrate your proactive approach to maintaining product quality.
✨Communicate Clearly
Since strong communication skills are key for this role, practice articulating your thoughts clearly and concisely. Be prepared to explain complex technical concepts in simple terms, as you may need to interact with various stakeholders during your time at Bespak.
✨Emphasise Continuous Improvement
Be ready to discuss how you've contributed to continuous improvement initiatives in your previous roles. Share specific examples of how you've monitored quality metrics or participated in Product Quality Reviews, as this aligns with the company's focus on quality excellence.