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.
We are looking for a Quality System Specialist to join our Team in Stamullen, Co Meath.
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 City North 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 for each site.
- 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.
- Perform cGMP internal audits.
- Assist in the performance of external audits.
- 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.
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.
Top Skills
What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
