Quality Systems Specialist

PCI Pharma Services; Dundalk (MD); On-site; USD 46,000 - 75,000; Full time

Job summary

PCI Pharma Services in Dundalk, Ireland, is seeking a full-time Quality Assurance professional to manage day-to-day QA activities within the City North unit. You will write and review SOPs, handle deviations, CAPAs, complaints, and QC documents, and support internal and external audits to ensure cGMP compliance.

Join a team focused on delivering high-quality therapies while fostering continuous improvement, training, and effective cross-functional collaboration across sites and regulatory bodies.

Qualifications

• Experience in pharmaceutical Quality Assurance.
• Knowledge of cGMP and regulatory requirements.
• Ability to write and review SOPs and QA documentation.

Responsibilities

• Write and review SOPs, Work Instructions, BPRs and forms.
• Write and review Deviations, Non-Conformance reports, Corrective Action Requests and prepare final reports for QP review.
• Support change control actions and drive on-time closure.
• Prepare quarterly reports for each site.
• Prepare Product Quality Review reports.
• Prepare & present monthly/annual metrics.
• Participate in cGMP internal audits and assist with external audits.
• Deliver QA training to relevant personnel.
• Assist with customer/regulatory audits and audit responses.
• Identify opportunities to improve processes and procedures.
• Lead ad hoc QA projects.

Job description

Stamullen, Co. Meath, IRL, Drogheda, Co. Loeth, IRL, Blanchardstown, Co. Dublin, IRL, Dundalk, Co. Louth, IRL

Full time

JR

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

The role is to implement and execute tasks relating to day-to-day Quality Assurance aspects. The role entails taking responsibility for Quality Assurance matters around processes and documentation in the City North business unit.

Key Responsibilities

• Ensure safe work practices are being followed at all times, report any near misses immediately to the EHS Department.
• Writing and reviewing SOP's, Work Instructions, BPR's and Forms.
• Writing and reviewing of Deviations, Non-Conformance reports, Corrective Action Requests and prepare the final report for QP review.
• Follow up on change control actions with appropriate action owners and drive for on time closure of actions.
• Prepare Quarterly reports for each site.
• Prepare Product Quality Review reports.
• Prepare & present Monthly/Annual Metrics.
• Complete complaints investigations and assist with close out of complaints.
• Perform cGMP internal audits.
• Assist in the performance of external audits (as required).
• Responsible for executing training for quality & other relevant persons.
• Assist with preparation for customer/regulatory audits.
• Assist with audit requests during customer/regulatory audits.
• Prepare responses to customer audits.
• Host/attend cross departmental meetings as required as quality representation.
• 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.
• Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company

#LI-JP1

Join us and be part of building the bridge between life changing therapies and patients. Let's talk future ( 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.

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