QA Officer

PCI TRGR Penn Pharmaceutical Services Ltd; Tredegar; On-site; GBP 26,000 - 38,000; Full time

Job summary

PCI Pharma Services in Tredegar is seeking a Quality Officer to uphold cGMP standards across manufacturing and packaging areas. You will provide QA guidance to Production and Packaging, review batch documentation, and ensure timely release of products, with a focus on continuous improvement and compliance.

You will work with Manufacturing, Packaging and Logistics to resolve quality issues, participate in audits, and support site QA leadership in ensuring regulatory compliance and product quality.

Qualifications

• Essential Knowledge: Working knowledge of cGMP standards employed at PCI.
• Experience: Experience of working in an Operational Quality environment.
• Skills and Aptitudes: High standard of written, listening and verbal communication skills.
• Proficiency with Microsoft Excel and Word; high attention to detail.

Responsibilities

• Train others in batch documentation review of critical process parameters for Manufacturing, Clinical and Packaging batches.
• Provide KPI’s for batch review and manage priorities/workload to ensure timely receipt and release.
• Perform start-up checks, Line Clearance and In-Process Checks in line with production schedules.
• Approval and inspection of Labels.
• Material checks prior to batch compilation.
• Support and drive online triage processes.
• Support Production to ensure containment actions are completed.
• Maintain the company pest control programme.
• Support GEMBA and LEAN activities within Production areas.
• Site-wide self-inspections and promote continuous improvement across all disciplines.
• Improve departmental processes to strengthen key controls and eliminate waste.

Skills

Quality Assurance

Operational Quality

Communication skills

Attention to detail

MS Excel

MS Word

Education

GCSEs including English, Maths and preferably science subjects

Tools

Microsoft Excel

Microsoft Word

Job description

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.

Main purpose of role:

Quality Accountability and Responsibility for Production Oversight & Approval, Error Identification and decision making on suitability 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. 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. The scope of the Quality Officer role covers all manufacturing and packaging areas across site. (*subject to entry and working practises and related SOPs).

Main responsibilities

• Technical/Quality Assurance Level 2 Fully trained in all aspects of Quality Officer (Operational) Level 1
• Be fully competent to train others in batch documentation review of critical process parameters of the Manufacturing, Clinical and Packaging batches.
• To provide KPI’s for batch review and manage priorities/workload to ensure that batches are received and released in a timely manner to meet schedules, service level agreements and customer expectations.
• To perform start up checks, Line Clearance and In Process Checks in line with the production schedule.
• Approval and inspection of Labels.
• Material checks prior to batch compilation.
• Support and drive online triage process.
• Support Production to ensure that all containment actions are completed.
• Maintain the company pest control programme.
• Support GEMBA and LEAN activities within Production areas.
• To perform Site Wide self-inspections and promote continuous improvement across all disciplines.
• Continuous Improvement Review and improve departmental processes to strengthen key controls and eliminate waste.

General/Other Duties

• Ensure compliance to cGMP and SOPs throughout the company.
• To drive and champion best practise for GMP processes – setting examples of high standards of gowning and personal hygiene.
• To undertake such tasks and to manage specific internal or ad hoc projects as and when required to meet department and business needs and within the scope of the job holder’s capabilities and responsibilities

Work experience & Skills required

Essential Knowledge: Working knowledge of cGMP standards employed at PCI. E.g. EU and US GMP for both drug products and medical devices.

Experience: Experience of working in an Operational Quality environment.

Skills and Aptitudes: High standard of written, listening and verbal communication skills. Basic to intermediate competence level in; Microsoft Excel Microsoft Word High attention to detail.

Personal Qualities and Behaviours

Customer focussed, Conscientious, Self-motivated, able to lead by example, an ability to get results through co-operation and influence.

Qualifications

Essential Minimum of 5 GCSE’s including English, Maths and preferably a science subject or equivalent pharma industry experience.

Desirable

The job holder will be ideally working towards higher education. E.g. BTEC, Degree or similar.

Regulatory/Industry Responsibilities General

The job holder is responsible for adhering to PCI Standard Operating Procedures (SOPs), Health, Safety and Environmental Rules, General Data Protection Regulations (GDPR), Good Manufacturing Practices (GMP) and other regulatory guidelines.

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.

Why work for PCI Pharma Services?

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.