Quality Systems Specialist

PCI Pharma Services; Blanchardstown; Hybrid; EUR 50,000 - 85,000; Full time

Job summary

PCI Pharma Services in Blanchardstown, Ireland, is seeking a Quality Assurance professional to implement and execute day-to-day QA tasks across processes and documentation in the City North business unit.

You will write and review SOPs, Deviations and CAPAs, lead audits, and prepare reports and metrics for regulatory and customer audits. A strong grasp of cGMP and QA systems, plus effective cross-functional collaboration, is essential.

Qualifications

• Quality Assurance experience in pharma manufacturing or similar regulated environment.
• Strong understanding of GMP/cGMP requirements and documentation controls.
• Proven ability to write, review and improve QA related documents.

Responsibilities

• Ensure safe work practices and report near misses to the EHS team.
• Write and review SOPs, Work Instructions, BPRs and Forms.
• Review Deviations, NCRs, CAPAs and prepare final QP review reports.
• Follow up on change controls and drive on-time closure of actions.
• Prepare site quarterly reports and Product Quality Review reports.
• Prepare and present monthly/annual metrics.
• Complete complaints investigations and assist with close out.
• Perform cGMP internal audits and assist with external audits.
• Execute QA training for quality personnel and others.
• Assist with customer/regulatory audits preparations and responses.
• Represent QA in cross-department meetings and identify process improvements.
• Lead ad hoc projects to meet department needs and goals.

Skills

Quality Assurance

GxP Knowledge

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.

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

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.