QA Officer Operations

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

The responsibility for this role is to assist the Quality Management Team in ensuring that all activities on the Tredegar and Oakdale sites are in compliance with the current Good Manufacturing Practise standards in accordance with company policies to meet business requirements.

This role operates on a three-shift rotating pattern (morning, afternoons and nights).

Main responsibilities

• Quality Accountability and Responsibility for Production Oversight & Approval, Error Identification and decision making on suitability to continue an operation.

• Oversight of Operations including Manufacturing, Primary and Secondary Packaging and Clinical labelling.

• Identify any potential risk to Quality during routine oversight.

• Ability to stop an operation due to quality risk identified.

• Ability to investigate and provide resolution to an identified issue.

• Ability to approve the re-starting of the line.

• To assist the Quality Management team in ensuring that all activities on the Tredegar and Oakdale sites are in compliance with the current Good Manufacturing Practise standards in accordance with company policies to meet business requirements.

• To work with primarily, the Manufacturing, Packaging and Logistics departments to provide QA guidance and expertise in the resolution of quality issues.

• To ensure the timely release of product by the review of the critical process parameters of the batch documentation to assess the quality, safety and efficacy of the products prior to Qualified Person certification, in accordance with agreed schedules and Service Level Agreements.

• To perform process and departmental audits against the relevant GMP standards to ensure continued compliance and improvement of systems and processes.

​Qualifications

• A degree in a scientific subject as a minimum

• GMP Skill Level 1 is desirable for this role.

• Previous laboratory experience is desirable.

• Self-motivated.

• Good communication skills.

• Honest and trustworthy.

• Proven ability and desire to continuously improve, by seeking new approaches and generating ideas.

• Strong time management skills.

• Team Player.

• Organised.

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.