Principal QA Validation Specialist

HERO

Job Detail

Location Limerick
Salary Negotiable
Posted
Role Type Permanent
Contact Mark Wilson
email talent@hero.ie

Principal QA Validation Specialist

Apply Now

Job ID: JOB-12510

Senior/ Principal QA Validation Specialist

Our Limerick based client, a globally renowned leader in Bio-technology are looking to attract a Senior & Principal level QA Validation Specialist to join their team on site on a permanent basis.

Summary: Validate/qualify equipment, systems, and processes in accordance with regulatory requirements and support, follow and implement company manufacturing standards policies and procedures

  • Generates, executes and/or reviews master and completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
  • Analyzes the results of testing and determines the acceptability of results against pre-determined criteria.
  • Investigates and troubleshoots problems which occur and determines solutions or recommendations for changes and/or improvements.
  • Reviews, edits and approves deviation notifications, deviation investigations, and corrective actions.
  • Reviews, edits and approves change controls, SOPs, reports and other documentation
  • Coordinates with other departments or outside contractors/vendors to complete validation tasks.
  • Collaborates with functional departments to resolve issues.
  • Trains/advises less experienced Specialists.
  • May supervise, provide direction and assign work to Validations Specialists and/or contingent workers to meet goals and deadlines.
  • Manage and drives projects and prepares status reports.
  • May present at both internal and external (regulatory) audits
  • Stays current with industry trends, regulatory requirement updates, and communicating same to team
  • May manage full time employees and/or contingent workers.
  • Performs other duties assigned by Management.
  • Some travel may be required.

  • BS/BA in Engineering, Chemistry, or Life Sciences plus 8 years related experience for Principal level
  • MSc 7 years related experience for Principal level

For further information on this role in please contact Mark Wilson on 0860449473 or email talent@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

Please Note: Under its obligation under the Data Protection legislation, HERO Recruitment will not forward your details to any company without your prior approval.

Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given.  You have supplied us with your personal data in the process of applying for a position.  Our client company may have personnel outside of the EEA who will review you data.  We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

 

Mark Wilson

JOB-12510

Apply Now

Principal QA Validation Specialist

Mark Wilson

Role Type Permanent
Contact Mark Wilson
email talent@hero.ie
mobile +353 86 044 94 73
linkedIn profile click here

Accounts Assistant

Galway

Apply Now Job ID: JOB-12597 Accounts Assistant Our client, a leading manufacturing company in Galway City, is …

 

Read More

Product Design Engineer

Galway

Apply Now Job ID: JOB-12596 Product Design Engineer Job Summary Reporting to the engineering manager, the project design engineer- MIS will support…

 

Read More

Quality Systems Engineer

Galway Mervue

Apply Now Job ID: JOB-12037 Quality Systems Engineer Our Client, a global leader in medical device manufacturing…

 

Read More