Job Information
PCI Pharma Services Quality Specialist - Technical in Tredegar, United Kingdom
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.
Interpret PQR data.
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.
Benefits
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.
On-Site Subsidized Canteen.
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. Let’s talk future (https://pci.com/)
Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.
Why work for PCI Pharma Services?
At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don’t say no, we figure out how.
PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled