The posting
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.
This role is on a 3 shift pattern - Days - Nights - Afternoons
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.
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.
