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.
General Purpose of Role:
• Maintain, support and improve the Pharmaceutical Quality System employed within PCI.
• Lead site activities in relation to computer systems validation.
Main Responsibilities:
• Manage and deliver specific validation projects according to business priorities.
• Write, review and approve validation documentation.
• Co-ordinate completion of annual computerised system reviews.
• Technical system Owner/Administrator for the site e-Document Management System and e-Quality Management System.
• Owner of site risk register and maintenance of Quality Risk Management and Data Integrity assessments.
• Line management responsibility for Quality Officers and/or Quality Administrators within the QMS stream.
• Represent the Bridgend Quality department for key client accounts.
• Reporting of metrics for systems within scope of responsibility.
• Support and host client audits of the PCI Bridgend facility.
• Support regulatory inspections of the PCI Bridgend facility.
• Support delivery of site/departmental projects and objectives.
• Support continuous improvement, validation and technical services activities.
• Author standard operating procedures.
• Provide QA and GMP related training.
• Additional duties as required with job level
Outcomes of Role:
• Maintain validated status of site GxP computerised systems.
• Co-ordinate site CSV projects.
• Maintenance of the compliance of site QMS.
Specific Qualifications:
• HND or degree (or equivalent) in a life sciences, engineering or IT related discipline.
• Experience generating, reviewing protocols, reports or technical documentation within a regulated industry.
Previous Work Experience:
• Good experience in a quality or technical role within a regulated industry (pharmaceutical, clinical, biotechnology or medical device).
• Working knowledge and practical experience with EU/US regulatory requirements (including but not limited to) Eudralex volume 4, Annex 11, Annex 15 and 21 CFR part 11.
• Line management experience would be advantageous.
Specific Knowledge / Skills Competence:
• Good GMP knowledge and experience of EU legislation and guidelines; experience with FDA GMP requirements CFR 210 and 211 other regulatory guidelines preferable.
• Strong communication skills.
• The ability to introduce, co-ordinate, complete and report on projects.
• A high level of self-motivation is required
• Able to rationally persuade.
• Ability to act as a Subject Matter Expert within area of responsibility.
• Ability to perform audits, internally and externally.
Behavioural Competencies:
• Communication skills – Must be able to communicate at all levels (internally and externally), using different methods and techniques ranging from written reports to formal presentations.
• Interpersonal skills – Able to form and maintain relationships at all levels is essential.
Join us and be part of building the bridge between life changing therapies and patients.