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.
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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.