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.

Main responsibilities

• 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.
• The job holder is responsible for the interpretation of GMPs for all manufacturing and packaging areas, including development and distribution stages with support from the Head of Quality and site QP’s.
• To perform batch documentation review (preferably in real time) of the critical process parameters of manufacturing, packaging and distribution operations to ensure compliance with written specifications, SOPs, GMP and GDP.
• To perform online batch review for packaging operations as guided by Quality Management to ensure compliance with written specification, SOPs, GMP and GDP.
• To support the review of corrections and training of operations team to reduce the reduction is Batch Record corrections.
• To ensure that following QA review that the batch is suitable for progression to the QP.
• Respond to client requests and batch comments in a timely manner and measure/act on these metrics.
• Complete Finished Product Inspections where applicable.
• Timely completion of tasks in line with business objectives
• To comply with company policies including internal and external Health and Safety and Environmental standards as required.

Qualifications

• A degree in a scientific subject as a minimum (preferably Chemistry).
• 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.

LI-AT1

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

• 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.
• The job holder is responsible for the interpretation of GMPs for all manufacturing and packaging areas, including development and distribution stages with support from the Head of Quality and site QP’s.
• To perform batch documentation review (preferably in real time) of the critical process parameters of manufacturing, packaging and distribution operations to ensure compliance with written specifications, SOPs, GMP and GDP.
• To perform online batch review for packaging operations as guided by Quality Management to ensure compliance with written specification, SOPs, GMP and GDP.
• To support the review of corrections and training of operations team to reduce the reduction is Batch Record corrections.
• To ensure that following QA review that the batch is suitable for progression to the QP.
• Respond to client requests and batch comments in a timely manner and measure/act on these metrics.
• Complete Finished Product Inspections where applicable.
• Timely completion of tasks in line with business objectives
• To comply with company policies including internal and external Health and Safety and Environmental standards as required