BGD_Qualified Person

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.

We are looking for a qualified QP or a QP trainee to join our Quality Team in Bridgend, Wales.

Main Responsibilities:

• To review Batch Manufacturing Documents to ensure compliance with UK and EU GMP and the Product Specification File/marketing authorisation (or other where relevant).

• To review Batch Documents for all operations performed at PCI Pharma Services (PCI).

• To certify Medicinal Products for use in the UK and EU and outside the EU (where relevant).

• To undertake audits in the UK, EU and third countries to ensure that Sponsor or MA Holder manufacturing sites are operating in general compliance with EU GMP

• To provide advice and guidance to PCI staff and Customers regarding QP requirements within the UK and EU.

• To keep up to date with the requirements of the Medicines Authorities across the UK, EU and rest of world (where relevant).

• To review PCI Project Files (PSFs, commercial project files etc) to ensure compliance with the current regulatory requirements and PCI procedures.

• To provide input and assistance with relevant elements of the Quality Management System (QMS) at PCI.

• Assistance with regulatory inspections and client audits.

• Perform Supply Chain Oversight when required.

Specific Qualifications:

Eligible to act as a Qualified Person (QP) for the certification of Marketed Products and Investigational Medicinal Products in accordance with UK legislation and EU directives 2001/83/EC and 2001/20/EC respectively.

Previous Work Experience:

Experience working as a QP in the certification of sterile medicinal products in particular Biopharmaceuticals manufactured aseptically.

Specific Knowledge / Skills Competence:

• Extensive QA experience within the medicinal products/ pharmaceutical industry.

• GMP Audit experience preferably qualified as Lead Auditor

• Experience in Biopharmaceuticals

• Experience in Sterile manufacture

• Effective Communication skills

• Good IT skills (at least MS Word).

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 contributions).
• 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 including enhanced maternity pay and returners bonus.
• Employee Referral Scheme: Know someone perfect for our team? Refer them and if appointed, receive £500 as our way of saying thank you!
• Employee 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 death in service cover up to 4 times your gross annual basic salary.
• Complimentary fresh fruit and breakfast items provided weekly.
• Cycle to Work Scheme.
• Development Opportunities: Invest in your future with our training programs, coaching opportunities, LinkedIn Learning, and further education options.

*Please note some of these benefits are non-contractual and therefore, may be subject to review and change.

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Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

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.

At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.