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 QA Specialist - Audit to join our team in Stamullen.
Summary of Role
The role is to implement and execute tasks relating to GMP auditing and supplier qualification in the PCI sites in Ireland.
Key Responsibilities
- Provide support during the preparation of client audits and regulatory inspections.
- Support all aspects of the site Supplier Management Programme, including supplier audits, risk assessments, preparation of QTA’s and supplier qualification.
- Co-ordinate backroom support activities for all major client audits and regulatory inspections.
- Track all audit responses and action items to ensure they are completed within agreed timeframes.
- Maintain, update and track the internal and supplier audit schedules including audit completion and response receipt.
- Raise Deviations, Corrective Action Requests, and Non-Conformance reports as required in a timely manner and ensure that issues are communicated to the auditing Manager/designee
- Ensure activities are in compliance with the requirements of cGMP
- Generation of SOP/Forms/JA's/WI's on MasterControl
- Interact and communicate daily with staff and support departments.
- To undertake such tasks and to manage specific and/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
Knowledge / Skills & Experience
Essential:
- Third-level degree in Chemistry, Biology, Pharmacy, Engineering, or a related field
- Minimum of 3 years in a similar role / working in Quality Assurance, Quality Systems, Compliance
- Good working knowledge of cGMP and associated regulations (Eudralex Volume 4; ISO 13485).
- To have demonstrable experience within Quality Systems.
- Capability to follow clear goals, communicate clearly and ensure progress to completion meeting predefined targets
- Ability to manage multiple tasks and set priorities.
- Good interpersonal skills.
- Willingness and ability to travel within Europe
- Strong analytical, communication, and reporting skills
- Proficiency in Microsoft Office and familiarity with quality systems (e.g., MasterControl)
- Good Written communication skills
Desirable:
- Supplier management and auditing experience
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.