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.
Main purpose of job:
The role is to implement and execute tasks relating to day-to-day Quality Systems aspects. The role entails taking responsibility for Quality Assurance matters around processes and documentation in the PCI Ireland business unit.

Main responsibilities:

• Writing and reviewing SOP’s, Work Instructions and Forms.
• Review of Deviations, Events, Non-Conformance reports, Corrective Action Requests, risk assessments provide support to departments on completion of records.
• Follow up on change control actions with appropriate action owners and drive for on time closure of actions.
• Prepare Quarterly reports
• Prepare Product Quality Review reports. (PQRs)
• Prepare Monthly Metrics and drive for closure of records
• Complete complaints investigations and assist with close out of complaints.
• Support cGMP internal audits.
• Responsible for executing training for quality & other relevant departments
• Assist with preparation for customer/regulatory audits.
• Assist with audit requests during customer/regulatory audits.
• Prepare responses to customer audits for Quality Systems related actions
• Host/attend cross departmental meetings as required as quality representation
• Host/attend customer Quality and Business review 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

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Join us and be part of building the bridge between life changing therapies and patients.
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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

• Writing and reviewing SOP’s, Work Instructions and Forms.
• Review of Deviations, Events, Non-Conformance reports, Corrective Action Requests, risk assessments provide support to departments on completion of records.
• Follow up on change control actions with appropriate action owners and drive for on time closure of actions.
• Prepare Quarterly reports
• Prepare Product Quality Review reports. (PQRs)
• Prepare Monthly Metrics and drive for closure of records
• Complete complaints investigations and assist with close out of complaints.
• Support cGMP internal audits.
• Responsible for executing training for quality & other relevant departments
• Assist with preparation for customer/regulatory audits.
• Assist with audit requests during customer/regulatory audits.
• Prepare responses to customer audits for Quality Systems related actions
• Host/attend cross departmental meetings as required as quality representation
• Host/attend customer Quality and Business review 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 capabilitie