Overview
Quality Assurance Specialist 3rd Party Products Jobs in Stamullen, County Meath, Ireland at PCI Pharma Services
Title: Quality Assurance Specialist 3rd Party Products
Company: PCI Pharma Services
Location: Stamullen, County Meath, Ireland
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.
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 Work with responsible site to complete corrections
Prepare Certification of Compliance (CoC) for QP
Work closely with QP as issues arise and find resolution
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
Essential
A degree or equivalent relevant experience.
Strong communication skills.
Proven ability to analyse and solve problems effectively.
Demonstrated capability to establish clear goals, articulate them effectively, and drive progress to achieve predefined objectives within set timelines.
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.
