Qualified Person in Tredegar

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

Main purpose of the role

The role involves organising and providing QP certification for pharmaceutical products—both commercial and investigational—with a primary focus on those manufactured and assembled at PCI Pharmaceutical Services Ltd, while occasionally overseeing products manufactured elsewhere, including third-country imports. It carries responsibility for ensuring timely, cost-effective, and GMP-compliant QP certification in line with service level agreements for both internal and external clients. In addition, the role forms part of the Quality Management team. This role is office based only.

Responsibilities

• Act as a named operational Qualified Person under the site manufacturing authorisations, and organise the certification of commercial and investigational medicinal pharmaceutical product. To maintain a register of all products certified.
• To maintain client contact to ensure all information and documents are available to allow release to occur.
• Devise, review, implement and manage systems within the group, including communication and information management, to achieve continuous process improvement.
• To liaise with Business Development in the preparation of proposals requiring QP input.
• To liaise with customer services to ensure invoices are raised promptly.
• Assist the Director of Quality to maintain the audit schedule for pharmaceutical products from outside the EU.
• To liaise with key clients when necessary and, as appropriate host client audits to ensure continued successful business relationships.
• To support the Director of Quality in interactions with UK and International regulatory bodies, taking an active part in hosting inspections.
• To ensure GMP compliance across the PCI Pharmaceutical Services Organisation by:
• Making regular visits to operational departments and offering advice and guidance with respect to regulatory expectations and recognised best practice.
• Supporting Line QA staff in their inspection and checking duties as required.
• Providing training to staff to increase understanding of the regulatory GMP requirements and implementation of best practices.
• Promoting compliance across the site by adherence to Quality Policies, SOPs and training programmes.
• Taking an active part in the self-inspection schedule.
• To provide advice and guidance to operational groups and clients.
• To perform external audits to facilitate the importation of Commercial or IMP materials, including Active Pharmaceutical Ingredient and finished product manufacturing and packaging sites or as defined to meet business needs.
• To perform audits of vendors and suppliers to PCI Pharmaceutical Services Limited, in order to maintain compliance with the approved supplier list as required.
• Approve Changes as per change control SOP and take an active role in the Change Control Committee when required.
• To take part in Deviation investigations and review of completed deviations.
• To provide reviews and reports as required summarising the performance of the Quality Management System in relation to Key Performance Indicators.
• To attend meetings of Quality Council to present summaries of any such reports.
• To keep abreast of current legislation (CPD).

Requirements

• A minimum of a first degree in Pharmacy, Chemistry or a Life Science or significant experience in a regulated pharmaceutical function.
• Eligible to act as a Qualified Person under Directive 75/319/EC (2001/83/EC) and Human Medicines Regulation 2012 SI 1916.
• A minimum of 5 years’ experience in a pharmaceutical Quality environment, with previous experience as a certifying QP preferable.
• Operational experience within a Pharmaceutical manufacturing or laboratory setting is desirable.
• Proficient in project management tools, with a proven ability to operate in an international company within a pre-defined timeframe.
• Excellent communication skills both verbal and written are required in this role and people management skills would be beneficial.
• Proven track record in the management and hands on hosting of Regulatory Inspections by international regulatory bodies.
• Computer literate with a minimum intermediate knowledge of Word, Excel, Project, Access, and PowerPoint (desirable).
• High standards of attention to detail and the desire to see tasks through to completion (desirable).

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.
• 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.

Join us and be part of building the bridge between life changing therapies and patients.

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, Equity and Inclusion 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.

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.