Connecting...

QA Validation Specialist

Job description

QA Validation Specialist

 

The QA Validation Specialist is responsible for oversight of validation activities on site ensuring compliance with current regulatory requirements. The QA Validation specialist will have specific and varying duties as assigned by the Quality Systems & Compliance Manager.  Some key tasks and responsibilities are outlined below: This is a permanent position in Dublin.

RESPONSIBILITIES:

  • Provide expertise in the area of validation at client’s location (TILGC), ensuring compliance with current industry regulations, guidelines and trends.
  • Reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.  Including but not limited to:
  • Qualification of premises, equipment and utilities.
  • Computer system qualification.
  • Laboratory equipment validation.
  • Process validation.
  • Cleaning validation.
  • Prepare and maintain policies and SOPs associated with validation.
  • Ensure that all TILGC change controls are assessed for impact on validation.
  • Review and Approval of TILGC validation master plans.
  • Review of deviations and non-conformances associated with validation activities.
  • Review and provide input into the TILGC periodic review and revalidation programme.

 

GENERAL RESPONSIBILITIES:

  • Participate fully in any cross functional training initiatives.
  • Actively foster, in cooperation with other TIL staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business.

Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event.

  • Ensure timely completion of all SOP, reading, training and assessment.
  • Other duties as required and directed by the relevant Manager or other Officer appointed by the Board of Directors.

 

EDUCATIONAL REQUIREMENTS:

  • Primary degree is scientific discipline.

 

RELEVANT EXPERIENCE:

  • A minimum of 5 years working within quality in the pharmaceutical industry.

 

 

If you would like to discuss this role, reach out to Louise Whitty on 021 2359140 / lwhitty@sigmar.ie

Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.