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Quality Operations Technician Dundalk, Dundalk
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Client:
PCI Pharma Services
Location:
Dundalk, Ireland
Job Category:
Other
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EU work permit required:
Yes
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Job Reference:
26aa32197286
Job Views:
4
Posted:
27.06.2025
Expiry Date:
11.08.2025
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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.
Responsibilities
* Generate Packaging Instructions, Batch Packaging Records and labels for use in production from Master documents.
* Perform AQLs as required during production operations.
* Sampling, approval and release incoming goods, packaging materials and product (where required) for use in production.
* Request Certificates of Analysis / Conformance for incoming goods, packaging materials and product from customers/suppliers. Review and filing of same.
* Review and filing of stock cards, approval forms, equipment LUMAC logs and other production logbooks.
* Identify training needs in conjunction with the production manager and conduct staff training as required.
* Assist with environmental monitoring procedures, update spreadsheets to facilitate trending of results.
* Ad-hoc checks, in-process checks and documentation review on a routine basis on production lines.
* Approval of Line clearance procedures.
* Approval of Pre-production samples.
* Maintenance of batch documents and retain samples in archive. Update the PQR database after QP release.
* To liaise with Customers / suppliers for artwork related queries and management of approval of artwork.
* Raise Deviations, Corrective Action Requests, Non-Conformance reports as required and in a timely manner and ensure that issues are communicated to the QC Manager/designee.
* Ensure activities observed are in compliance with the requirements of cGMP.
* Ensure safe work practices are being followed at all times, report any defects immediately to the Safety Officer and attend Health & Safety meetings.
* Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company.
* Carry out various other additional tasks that may be required from time to time in accordance with the overall goal of the company
* Degree and/or relevant experience
#LI-MS1
Join us and be part of building the bridge between life changing therapies and patients.
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