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.
Job Title: Quality Assurance Specialist – 3rd Party Products Department: Clinical Quality Division / Section: Quality Assurance Accountable to: Qualified Person / Accountable for: (people manager) N/A Summary of Role This is an exciting role as part of the Batch File Review Team.
This role will appeal to anyone who enjoys a high degree of variety in their role.
This role involves networking and communication across multiple stakeholders both internal and external to PCI.
Batch file review encompasses all process types, OSD, Sterile, Biologics, Cell Therapy, Gene Therapy etc.
Ideal grounding for anyone thinking of a future career as a QP.
Part of the Batch File Review Team who: Compile batch documents Review batch documents in advance of QP review.
Review analytical data.
Work with responsible site to complete corrections Prepare Certificate of Compliance for QP.
Work closely with QP as issues arise and find resolution Review of regulatory documentation and liases with Regulatory compliance team to trouble shoot issues.
Perform a batch file review for batches manufactured/packed at PCI or in third party company.
Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QA Manager/QP.
Request Certificates of Analysis / Conformance for API/Drug Substance, Bulk Product, Packaging records from customers/suppliers.
Review records against approved filing/Dossier of same.
Coordination of every product supply chain flow – products which are coming from rest of the world and releasing to the European Union Participating customer meetings – discussion/collection/summary about the necessary quality documentation Writing SOPs or Work Instructions Maintenance of batch documents and retain samples in archive room.
Update the PQR database after QP release.
Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
Knowledge / Skills