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Quality Operations Technician Dundalk

1 month ago

The Municipal District of Dundalk, Ireland PCI Pharma Services Full time

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Quality Operations Technician Dundalk, Dundalk

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Client:

PCI Pharma Services

Location:

Dundalk, Ireland

Job Category:

Other

-

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

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Join us and be part of building the bridge between life changing therapies and patients.

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