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Quality Engineering Specialist, Stamullen
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Client:
PCI Pharma Services
Location:
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
19bca6e4731d
Job Views:
4
Posted:
15.06.2025
Expiry Date:
30.07.2025
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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.
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.
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