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Quality Specialist - Technical, Tredegar
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Client:
PCI Pharma Services
Location:
Tredegar, United Kingdom
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
d0dca529901d
Job Views:
2
Posted:
05.05.2025
Expiry Date:
19.06.2025
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Job Description:
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
The role
This role is a key player in ensuring excellence and regulatory compliance, as provides a vital technical quality support for both new and ongoing projects, interpreting and applying business and regulatory guidelines.
We are looking for a someone with a critical decision-making, as the job holder will review and approve deviations and change controls, as well as addresses non-compliance issues, and initiates quality improvements.
Main responsibilities
To provide technical Quality support to the Operational departments for new and ongoing projects.
Play a lead role in the interpretation of business and regulatory (EU/US/Japan) guidelines which assists with regulatory compliance.
To promote a sense of quality throughout the site business units so as to raise manufacturing/ development/clinical performance and eliminate waste caused by unnecessary compliance errors.
To conduct performance audits and follow up on actions within site business units.
Review and approve, for all areas, Master Batch Records (MBR), master despatch job cards, Technical specifications and addendums, master label approvals, returned Technical Specifications and Technical Agreements.
Write and review Drug Product Files (DPFs), Product Specification Files (PSFs)
QA approval of Item Masters.
Batch record compilation and regulatory checks.
Review and approve Deviations and Change Controls as needed.
To review non-compliance identified by audit, deviations and complaints, and use technical / professional judgment to make the appropriate product quality decisions (in association with site QP’s), and to initiate and promote quality improvements to prevent re-occurrence.
To ensure that products proposed for release by a site QP were manufactured in accordance with license requirements, clinical trial application and cGMP.
To assist with GMP training within the department and cross site.
At PCI, we believe that our employees are our most valuable asset. That's why we are committed to providing a benefits package designed to support your well-being and enhance your overall quality of life. Here's what we offer:
Employer Pension:Secure your future with our employer pension scheme (above statutory pension).
Competitive Salaries:We offer competitive salaries that reflect your dedication and contributions.
Generous Annual Leave:Enjoy 25 days of annual leave, plus bank holidays.
Family Friendly Benefits:Enjoy a range of benefits designed to support your family life.
Employee Referral Scheme:Know someone perfect for our team? Refer them and receive £500 as our way of saying thank you!
Staff Engagement:We value your dedication with recognition schemes and long-service awards.
Health and Well-being:Your health matters. Count on our support with generous sick pay, access to a 24/7 GP through our employee assistance program, mental health support, and life assurance up to 4 times your annual salary.
Cycle to Work Scheme.
Development Opportunities:Invest in your future with our training programs, coaching opportunities, LinkedIn Learning, and further education options.
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Join us and be part of building the bridge between life changing therapies and patients.
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