Computer Systems Quality

Computer Systems Quality (CSQ)

• Location: Waterford
• Job Type: Full-time, Contract

Job overview
Sanofi is a leading global healthcare company with a passion for meeting patients' needs, a diverse dynamic working environment committed to their employee's development and wellbeing. The position being advertised is an exciting and challenging CSQ Engineer role with a focus on Computer Systems Validation.

The 12-month role will be based in the Sanofi Waterford site. The role will support digital projects. The role will require you to work within the site quality systems team but also cross-functionally across site departments, where applicable.

Previous CSQ experience in sterile manufacturing, solid dose and devices would be highly advantageous for the role in particular Digital Projects.

Responsibilities
The following activities will be included as part of your role:

• Prepare a local validation protocol and report.
• UAT (User Acceptance Testing) plan to verify that the system performs as expected in its local environment including (but not limited to) software function, end-to-end process flows, user training adequacy, local procedures fitness for purpose, load/stress performance testing, exception case testing etc.
• UAT prepared by and pre-approved and on completion by delegated Users the post approval to be completed as CSQ as final reviewer.
• Local data migration verification - To supplement global migration testing documentation, use a sample of data (various means of verifying this including but not limited to record counts, record size counts, and direct record content comparison in the source and target/ QualiPSO systems).
• Interface testing of global and any local interfaces not addressed by the upgrade, or any interface procedural workarounds.
• Updates to Computerised System inventory list.
• Review Global validation materials (e.g. URS, GxP RA, VMP, Configuration Specs, Design Review, Installation Testing, Functional Testing, Release Testing, Automated testing tool assessments [ref. EU Annex 11], & Validation Report) to gain understanding of the global verification process to inform gaps in site validation strategy.
• Review the relevant documentation as listed above from a CSV and Quality role under the title of Computer Systems Quality (CSQ) as part of the global project approval process.
• Ensuring validation studies are managed in conjunction with all required Sanofi standards and legal requirements (Health & Safety, cGMP, construction, environmental etc.).
• Participation in external regulatory inspections.

Requirements & Qualifications:

• Relevant Engineering or Science qualification. Previous validation experience in sterile manufacturing, solid dose and devices would be highly advantageous for the role.
• Experience, qualification, or knowledge of Computer Systems Validation would be desirable.
• Working knowledge of the CSV lifecycle model elements and requirements.
• Awareness of GAMP 5 - A Risk-based Approach to Compliant GxP Computerised Systems.
• Awareness of EudraLex GMP Annex 11 - Computerised Systems; FDA 21 CFR Part 11 - Electronic Records, Electronic Signatures, Final Rule.
• Strong understanding of the CSV lifecycle model elements & requirements. Familiarity with GAMP 5, EU GMP Annex 11 - EudraLex Volume 4 - EU guidelines to Good Manufacturing Practice - Products for Human and Veterinary Use, Annex 11: Computerised Systems.
• [21 CFR Part 11] Food and Drug Administration Code of Federal Regulations - Electronic Records, Electronic Signatures, Final Rule.
• General Principles of Software Validation; Final Guidance for Industry and FDA Staff.

What makes this position unique?
You will have the opportunity to work in an energetic friendly team where teamwork is essential.

Due to the diverse of the site and the validation work, you will get exposure to many areas of the business with the chance to grow your career and develop your technical and professional skills.

Benefits of working in this role
Sanofi is committed to training and development. Due to the cross-functional nature of the validation work you will get exposure to many areas of the business.

As part of the role, there will be opportunities to work on validation / CSV activities within sterile manufacturing, solid oral dose, and devices. There will also be opportunities for both technical and professional development.

Apply today or contact myself at [email protected] for further information.