QA Officer (Audit)

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 : To perform a Quality Assurance role which supports:

• Hosting Audits to ensure compliance with regulatory standards, company policies, and project requirements.
• Maintain, support and improve the Pharmaceutical Quality System employed within PCI.
Main Responsibilities:
• Support the QP in execution of their legal and operational duties.
• Administration, control and support core systems within the Pharmaceutical Quality system as allocated by line manager. Including but not limited to Internal audits, vendor management, deviations/complaints, CAPA, change control and document control.
• Reporting of metrics for systems within scope of responsibility.
• Support and host client audits 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.
Outcomes of Role:
• Schedule, host and close out client audits.
• Pre-certification assessment of batch records and generation of draft QP certificates.
• Post QP certification batch release via the inventory system.
• Review and approval of offsite shelf life extension labelling activities.
• Pre-approval assessment of change controls and deviations.
• Co-ordinate and perform investigations into internal and external quality issues.
• Assess temperature excursions during shipment in line with the stability priofile of the product(s).
• Approval of completed investigations, CAPA's and change controls.
• Schedule, perform and close out internal and external audits within established timelines.
• Pre review of validation/qualification protocols.
Join us and be part of building the bridge between life changing therapies and patients. Let's talk future (https://pci.com/)

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, Diversity, Equity, and Inclusion (DEI) 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. Why work for PCI Pharma Services? At PCI, we have an uncompromising focus on providing quality and operational excellence and providing the industry leading customer experience. Our people make all of this happen, so providing an industry leading experience for our people is equally as important. By creating an authentic culture of purposeful work, we aspire to be an interesting and fulfilling place for talented individuals to grow careers. We live a philosophy of intentional learning combined with real-life experience supported by a fair and competitive rewards program. We are individuals, teams and a company that believes in our purpose and our approach is simple, the people who work at PCI fuel our business; we don't say no, we figure out how. PCI Pharma Services is an Equal Opportunity Employer/Vet/Disabled