QA Validation Specialist (CSV)

HERO

Job Detail

Location Limerick
Salary Negotiable
Posted
Role Type Permanent
Contact Michael Brennan
email hire@hero.ie

QA Validation Specialist (CSV)

Apply Now

Job ID: JOB-12483
Our client is currently looking to fill a QA Computer System Validation Specialist position. This position will implement policies and procedures to validate/qualify computer systems/Infrastructure. Plans, coordinates, and participates in a compliant validation process for quality information technology systems which requires formal validation documentation under appropriate regulatory requirements and company manufacturing standards.

In this role, a typical day may include the following:

  • Generates, executes and/or reviews completed qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria
  • Analyzing the results of testing and resolving acceptability of results against predetermined criteria
  • Investigating and troubleshooting problems which occur and determines solutions or recommendations for changes and/or improvements
  • Identifying current and anticipated requirements for computerized operations and suggests methods for the identification, implementation, and maintenance of the procedures, actions, and documentation vital to ensure compliance within the operation
  • Leading process improvement projects to improve the validation of computerized systems
  • Coordinating with other departments or outside contractors/vendors to complete validation tasks
  • Participating in regulatory audits and communicates computer validation policies
  • Assessing computer systems and identifies any potential Part 11 or Annex 11 gaps and ensure the best data integrity practices are enforced
  • Training less experienced Specialists and Technicians
  • Generating, reviewing and approving of Validation documents

This role might be for you if you:

Possess a thorough understanding and experience of Validation principles with good knowledge of GAMP 5, ICH Q7A, FDA parts 210 and 211
Have technical writing experience
Have a strong attention to detail and accuracy
Are experienced in risk assessments in relation to validation activities

To be considered for this role you must hold a Bachelor’s degree in Engineering, Chemistry, or Life Sciences with 3+ years of related experience within the fields of computers and biotechnology for the Specialist level, 5+ years experience for Senior level. Experience with IT/Automation/QC Enterprise systems desirable. Will substitute relevant experience for education. Level is determined based on qualifications relevant to the role. Our client has an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!


For further information on this QA Validation Specialist (CSV) role in Galway please contact Michael Brennan on 086 4403742 / hire@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.

Michael Brennan

JOB-12483

Apply Now

QA Validation Specialist (CSV)

Michael Brennan

Role Type Permanent
Contact Michael Brennan
email hire@hero.ie
mobile +353 86 440 37 42
linkedIn profile click here

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