Overview
Qualified Person role at Bespak, on a permanent basis, onsite at the Holmes Chapel site, CW4 8BE. The salary for this role is £80k to £90k plus a discretionary annual bonus. Other benefits include 25 days leave plus bank holidays, discretionary annual bonus, a generous 10% pension contribution, onsite free parking, and medical / dental / health / life assurance.
Days shift pattern: Monday to Friday (8:30am to 9:00am start; 4:30pm–5:00pm finish; Friday finish possible at 3:45pm). Some flexibility on start and finish times.
Bespak in Holmes Chapel is an Investors in People Silver Award-winning pharmaceutical CDMO with over 350 employees, currently expanding. We are investing to increase our capacity for developing and manufacturing sustainable pMDIs (asthma inhalers) with greener propellants, meeting evolving industry standards, while providing development, manufacturing, filling and finishing solutions for medical devices including SMIs, DPIs, nasal sprays and medical check valves.
Responsibilities
* Certify commercial and clinical product batches in line with UK legislation (SI 2012/1916 & 2004/1031).
* Review and approve batch-related documentation, GMP records and Quality Agreements.
* Develop and review SOPs, validation protocols, change controls, complaints, and specifications.
* Monitor, maintain and improve quality systems and ensure readiness for inspections (MHRA, FDA).
* Incorporate Regulatory trends and changes into the Holmes Chapel site.
* Act as a QA lead in cross-functional improvement initiatives and technical investigations.
* Conduct self-inspections and vendor audits, driving continuous improvement and CAPA effectiveness.
* Provide GMP coaching to site teams to support right-first-time performance.
* Provide rapid escalation and resolution of quality issues.
* Proactively identify risks and mitigations.
* Support Customer and Regulatory Inspections.
Qualifications and key skills
* Registered Qualified Person under current UK legislation.
* Experience in pharmaceutical manufacturing and QP-related duties.
* Strong understanding of cGMP and global regulatory requirements.
* Experience across various dosage forms and product lifecycle stages is desirable.
* Skilled in fostering a strong quality culture and influencing cross-functional teams.
* Experience with audits and inspections and communicating with regulatory agencies.
Benefits
* 25 days 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 village in Cheshire with good transport links, proximity to motorways and Manchester Airport, and access to nearby national parks. The area offers a range of amenities and excellent connectivity.
Sustainability and certifications
We align our BZero sustainability initiative to the SBTi certification, targeting net zero, and we hold ISO 14001, 45001 and 13485.
A full job description can be downloaded on the application screen.
Culture and commitments
Our core values are Customer Focused, Respectful, Collaborative, and Agile. We support flexible working arrangements where possible to enable a healthy work/life balance. We are committed to diversity and inclusivity, and we are a disability-positive employer. We will provide adjustments during the recruitment process if required; please contact the Recruitment Team for support.
By applying to this role, you consent to Bespak Limited processing your personal data for employment/recruitment purposes. All personal data is protected under GDPR. For details, please visit our privacy policy or contact the local HR team.
Strictly No Agencies - Our in-house recruitment team manages all our vacancies.
Job details
* Seniority level: Mid-Senior level
* Employment type: Full-time
* Job function: Quality Assurance and Manufacturing
* Industries: Pharmaceutical Manufacturing, Medical Equipment Manufacturing, and Manufacturing
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