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.
We are looking for a QA Regulatory Compliance Specialist (FT maternity cover).
Main purpose of job:
The role is to implement and execute tasks relating to the introduction and maintenance of third party/clinical products within the clinical regulatory compliance department in PCI.
Main responsibilities:
Creation and maintenance of Products Specification File (PSF) for Clinical supply chain where QP certification is performed.
Developing and managing Quality Systems & Compliance to support the maintenance and release of clinical supply chains at PCI.
Maintenance of Approved CMO list for Clinical Supply Chain
Maintenance of Supply Chain/CMO Risk Register, highlight at risk sites that need additional support or remediation.
Ensure on-going compliance with customer, regulatory and internal requirements.
Management and co-ordinate Supplier Management Programme, including supplier audits, preparation and review of quality technical agreements, supplier qualification and vendor performance for third party suppliers.
Preparation and maintenance of the third party/clinical approved products and supplier lists.
Preparation of QP declarations for review and approval by third party QP at PCI
Preparation and review of product quality reviews for third party QP release.
Review and track third party change controls which have a product quality or regulatory impact.
Support the management of the Manufacturing and Importation License held by Millmount entity and the associated variations to it.
Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required in a timely manner and ensure that issues are communicated to management.
Generation of SOP/Forms/Job Aids/Work Instruction's on the Master Control system
Identify and support opportunities for improving processes and or procedures.
To undertake such tasks and to manage specific or ad hoc projects as and when required to meet department and business needs and within the scope of the job-holder’s capabilities.
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.