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Job ID: JOB-13402

QA IT Engineer

About the role:

The QA IT Engineer will be responsible for on-going IT application and compliance support within the IT Team. S/he will need to have experience in implementing and supporting IT applications, technical writing and document management in a regulated environment.

The QA IT Engineer will need to have a strong quality background to maintain quality standards in a GMP environment.

The position will work within a collaborative IT team and will be required to have excellent communication/interpersonal skills with the ability to work on their own initiative.

Experience of working in a pharmaceutical API manufacturing operation is desirable.

Responsibilities:

• Modify and Review existing CSV & Compliance documentation (e.g.  Standard Operating Procedures, templates, strategy documents) focusing on continuous improvement and following up on gaps or discrepancies
• Perform Security Reviews and Periodic Reviews for IT systems
• Work directly with System Administrators/Subject Matter Experts and Quality Assurance Representatives ensuring ongoing compliance with Lilly Quality Standards and Practices
• Communicate with stakeholders to understand and clarify software requirements
• Support of Sharepoint and IT applications
• Execute test scripts, analyze test results and determine the acceptability of results against pre-determined criteria
• Work with the business to identify and implement procedural controls to mitigate issues found during testing
• Lead procedural improvements that will increase efficiency and consistency of the validation process
• Maintain tracking system for compliance actions and provide bi-weekly updates
• Generate computer system validation documentation in accordance with site procedures and GMP guidelines
• Support and participate in site audits.

Requirements:

• Minimum 3-5 years’ experience implementing and supporting IT applications in a GMP environment
• Experience in product life cycles from requirements through design, testing and delivery of the system into production
• Good knowledge of cGMP required to understand the quality systems on site
• Background in software development, systems analysis/configuration and Computer System Validation documentation
• Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally.
• Experience implementing changes for IT applications in a GMP environment
• Attention to detail and accuracy
• Ability to meet deadlines

For further information on this role in Software Engineering please contact Michael Brennan on Hire@hero.ie  or 086-440 3742

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

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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.

Michael Brennan

JOB-13402

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