Job Information
PCI Pharma Services Quality Engineering Specialist in Stamullen Co. Meath, Ireland
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:
As a Quality Engineer at PCI Pharma Services, you will play a critical role in ensuring the quality and compliance of pharmaceutical packaging processes. You will work in a dynamic environment where attention to detail and a strong understanding of regulatory requirements are essential. Your responsibilities will include quality assurance, process improvement, and collaborating with cross-functional teams to meet the highest industry standards.
Main Responsibilities:
Conduct routine inspections of packaging processes to ensure compliance with regulatory standards (e.g., FDA, EMA, ICH).
Perform risk assessments and analysis of critical parameters in packaging operations.
Monitor and enforce adherence to cGMP, GDP, and other relevant quality systems.
Implement quality control procedures, including visual inspections, sampling, and testing, to verify product integrity.
Manage non-conforming product investigations and root cause analysis.
Maintain comprehensive records of all quality activities, including batch records, deviations, CAPA reports, and change controls.
Assist in the creation and revision of standard operating procedures (SOPs) to align with quality standards.
Identify opportunities for process optimization and quality enhancement.
Provide recommendations for corrective and preventive actions to resolve quality issues and enhance efficiency.
Participate in equipment and process validations (IQ, OQ, PQ) to ensure equipment and systems meet predefined quality and performance criteria.
Coordinate validation activities and create validation protocols.
Prepare for and participate in internal and external quality audits and regulatory inspections.
Implement corrective actions in response to audit findings.
Collaborate with production, engineering, and other departments to resolve quality-related issues.
Provide training and guidance to production staff on quality and compliance matters.
Stay updated on industry regulations and emerging trends in pharmaceutical packaging.
Collect, analyse, and interpret data to identify trends and areas for improvement.
Generate quality reports and metrics for management review.
Attention to detail and a commitment to ensuring product quality and safety.
Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future (https://pci.com/)
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.
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