Quality Assurance Specialist

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
Responsible for Quality Accountability, Production Oversight, and Approval to Run. This includes error identification, pre-QP review of investigations, and making decisions on the suitability of continuing operations and progressing batches to QP certification.

This role operates on a two-shift rotating pattern (morning and afternoon shifts).

Main Responsibilities

• Provide quality oversight of Manufacturing, Primary and Secondary Packaging, and Clinical Labelling operations

• Identify and assess quality risks during routine operations, with the authority to stop production where required

• Investigate quality issues, provide resolution, and approve the restart of production lines

• Make decisions on product suitability for use, rejection, and progression to QP certification

• Support Quality Management to ensure compliance with GMP standards, company policies, and regulatory requirements across the Tredegar and Oakdale sites

• Collaborate closely with Manufacturing and Packaging teams to provide QA guidance and resolve quality issues

• Interpret and apply GMP regulations (MHRA/EU/FDA) to all manufacturing and packaging activities, including development, clinical, commercial, and unlicensed products

• Evaluate complex quality data, making professional decisions to ensure compliance while meeting business deadlines

• Influence and advise stakeholders at all levels, up to director level, on quality matters and conflict resolution

• Ensure quality is built into facilities, processes, and products, and liaise with clients as needed

• Lead and manage team members (if applicable), ensuring KPIs, targets, and deadlines are met

• Uphold high ethical standards in line with stringent pharmaceutical regulatory requirements

• Ensure adherence to SOPs, working practices, and entry requirements across all manufacturing and packaging areas

Requirements

• Educated to degree level or equivalent in a science or QA-related discipline

• Experience in an operational quality environment

• GMP Skill Level 1 (desirable)

• Strong written, verbal, and listening communication skills

• High attention to detail and analytical ability

• Basic to intermediate IT competence

• Customer-focused, conscientious, and self-motivated

• Able to lead by example and achieve results through cooperation and influence

• Ideally a member of a professional body recognised by the UK MHRA

• Please note that candidates with a lower-level qualification but significant QA pharma industry experience will also be considered

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

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.