QC Coordinator

  • Cork
  • Permanent
  • JO-1905-64470_1565175654

Summary

Responsibilities:

* Format, deliver and review necessary documentation in line with the standard approval process, and facilitate others to do so in compliance with GMP requirements.

* Filing documentation - Support divisional activities through documentation generation, filing, tracking,

* auditing and maintenance of associated databases.

* Manage creation and administration of SOP's/TM's/WI's. Editing and formatting existing documents.

* Preparation and issue of new documentation for review

* Facilitate all required supporting documentation.

* Maintain control and issuance of logbooks.

* Reviewing of CAPA's and deviations for the department

* Involvement in lab equipment validation

* Preparation of reports e.g. ILI/Investigation/Memo

* Liaise with external suppliers/vendors in relation to QC consumables

* SAP - new vendor set up, PO requests, etc.

* Provide support for Audit preparations and projects

* Maintain and upkeep of all training files and certificates for the department

* Involvement in the maintenance and control of data integrity for the department.

* Participation in Lean activities on site

* Ad hoc support to the department as required

Requirements:

* 3 - 5 years' QC experience within a GMP environment supporting the pharmaceutical industry

* Experience of Microsoft Office, SAP

* Strong team player with the ability to work collaboratively and cross functionally

* Excellent organisation and communication skills

* Ability to work on own initiative.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

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