Role Purpose:

  • A new opportunity has arisen for a Software Quality Engineer to join our client’s new manufacturing facility in Co. Kilkenny.
  • In this role you will be responsible for creating and implementing the Company’s validation program.
  • Creating and maintaining validation documentation for new and existing systems and processes subject to design control.
  • You will also ensure that validation activities are implemented for systems as per requirements and standards as listed in their current Quality Systems Manual.
  • You might also travel to vendor locations for training in Europe or the US.
  • Previous experience in implementing software projects from greenfield stage.

Core Duties and Responsibilities:

  • The validation and operational management of computerized systems.
  • The creation and review of validation documentation in accordance with regulatory requirements and divisional policies.
  • Responsible for creating Software Compliance assessments such as 21 CFR Part 11 and Data Integrity.
  • Maintaining the quality and compliance status of associated Procedures, work instructions.
  • Presenting and communicating status, report metrics, identify trends potential issues, improvement initiatives, as applicable.

Education & Qualifications Required:

  • Relevant third level qualification. IT/ Engineering/Manufacturing/Science is preferred.
  • 2-3 years working knowledge of software validation in med devices industry.
  • Experience working in a 21CFR820 and/or ISO13485 regulated industry.
  • May consider experience in pharmaceutical validations

Please note, we do not require agency assistance with this role.


Apply Now

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Full Name*
Accepted file types: pdf, docx, odt, doc, txt, Max. file size: 32 MB.
Accepted file types: pdf, docx, odt, doc, txt, Max. file size: 32 MB.
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Role Details:

Job Title: Software Quality Engineer
Location: Kilkenny
Type: Permanent
Date: July, 2024
Image of recruitment specialist

Discuss with:

Ruth Holland
recruitment@prochem.ie
Recruitment Specialist
on +353 56 779 0100
Share:

Role Details:

Job Title: Software Quality Engineer
Location: Kilkenny
Type: Permanent
Date: July, 2024
Image of recruitment specialist

Discuss with:

Ruth Holland

recruitment@prochem.ie

Recruitment Specialist

on +353 56 779 0100

Share:

Role Purpose:

  • A new opportunity has arisen for a Software Quality Engineer to join our client’s new manufacturing facility in Co. Kilkenny.
  • In this role you will be responsible for creating and implementing the Company’s validation program.
  • Creating and maintaining validation documentation for new and existing systems and processes subject to design control.
  • You will also ensure that validation activities are implemented for systems as per requirements and standards as listed in their current Quality Systems Manual.
  • You might also travel to vendor locations for training in Europe or the US.
  • Previous experience in implementing software projects from greenfield stage.

Core Duties and Responsibilities:

  • The validation and operational management of computerized systems.
  • The creation and review of validation documentation in accordance with regulatory requirements and divisional policies.
  • Responsible for creating Software Compliance assessments such as 21 CFR Part 11 and Data Integrity.
  • Maintaining the quality and compliance status of associated Procedures, work instructions.
  • Presenting and communicating status, report metrics, identify trends potential issues, improvement initiatives, as applicable.

Education & Qualifications Required:

  • Relevant third level qualification. IT/ Engineering/Manufacturing/Science is preferred.
  • 2-3 years working knowledge of software validation in med devices industry.
  • Experience working in a 21CFR820 and/or ISO13485 regulated industry.
  • May consider experience in pharmaceutical validations

Please note, we do not require agency assistance with this role.

Image of recruitment specialist

Discuss with:

Ruth Holland
recruitment@prochem.ie
Recruitment Specialist
on +353 56 779 0100
Share:

Apply Now

"*" indicates required fields

Full Name*
Accepted file types: pdf, docx, odt, doc, txt, Max. file size: 32 MB.
Accepted file types: pdf, docx, odt, doc, txt, Max. file size: 32 MB.
Hidden
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