Quality Associate

Website Wasdell Group

We are now recruiting for our new facility in Dundalk, Ireland

The Wasdell Group is one of the largest, most experienced pharmaceutical outsourcing partners to the healthcare industry in Europe, and we are currently recruiting the role a Quality Associate who will be based at our packaging facility in Dundalk, Ireland.

The Quality Assurance Officer will report to the QA Manager/ Head of Quality

The Quality Assurance Officer has the following responsibilities:

  • Administration of the Quality Manual, including assuring that SOPs are reviewed and current versions are available to appropriate staff.
  • Recording of deviations on the company database.
  • Follow up of CAPA.
  • Supplier complaints (recording, investigation and reporting).
  • Change control.
  • Product Quality Review.
  • Preparation of Master Batch Records for selected licensed medicines.
  • Internal audits and External audits
  • Technical dossier creation and upkeep.
  • Oversight and monitoring of sites BMS Temperature control.
  • Revision of Master Batch records.
  • Customer samples, Archiving, Creating log Books
  • The Quality Assurance Officer is responsible for:
  • Review of batch documents prior to their issue to production
  • Review of documents for completed batches prior to QP or QA Manager or Head of Quality release
  • The despatch of customer samples as required.
  • Transmission of certificates and copies of batch documents to the customer as required.
  • Assisting in Validation activities when required.
  • Designated Quality contacts for allocated customers.
  • Retain samples..
  • Supporting the Head of Quality and QA Manager during Regulatory inspections and supporting Customer Audits.
  • Support the QC Goods in function as required.

This role is full time, working on a Monday – Friday basis with a competitive salary and benefits.

Please note: We are unable to respond to all applications and therefore, if you have not heard back from us in four weeks, we regret to confirm you have not been successful in your application.

To apply for this job email your details to jobs@wasdell.eu

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