Job Description

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

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 & Experience

Essential:

• Degree and/or relevant experience.

• 5 years of Quality experience.

• Experience of working in a GMP environment.

• Good communication skills.

• Steriles experience is desirable.

• Ability to problem solve.

· Capability to set clear goals, communicate these clearly and ensure progress to completion/meeting predefined targets.

· Proven track record of showing how results were delivered through management/leadership of others.

· Capability to set clear goals, communicate these clearly and ensure progress to completion meeting predefined targets.

· Team player

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.