Quality Validation Engineer
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| Job Type | Contractor |
| Location | Sligo |
| Area | Sligo, Ireland |
| Sector | Quality |
| Start Date | |
| Advertiser | Darcy Ainscough-Denton |
| Telephone | +353 1 574 6266 |
| Job Ref | 2572 |
| Job Views | 224 |
- Description
- Quality Validation Engineer – Team Horizon
We are currently recruiting an ambitious and experienced Quality Validation Engineer for our client who are a global biopharmaceutical leader, for their Sligo site.
Why you should apply:
Our client has developed a stand-out culture of innovation, inclusion, and development, and consistently features as a great place to work.
The role is generously compensated and attracts a competitive base salary and highly attractive benefits package.
Excellent career progression opportunities.
What you will bedoing:
Develop and execute the qualification for Information Systems and GxP software systems.
Develop of life cycle documents necessary to address the validation lifecycle for Information Systems and GxP software systems (Planning, Risk, Implementation, and maintenance of the validated state).
Review of RCE/URS for new computer/automation/enterprise systems to ensure new systems meet AbbVie and regulatory requirements for computerised systems and data integrity ·
Coordinate with other global divisions, departments and/or outside contractors/vendors to implement/support the successful application of new technologies/ systems and ensure that the system design meets technical, customer, and regulatory requirements.
Lead the definition, design, and execution of computer/automation/ enterprise systems validation and verification activities throughout all phases of the SLC Ensure all plant personnel are fully aware of quality requirements (where relevant) by providing the necessary training.
Ensure Management is kept informed of all system failures to ensure corrective/preventive action and product containment is taken where necessary.
Ensure Quality System documentation is thorough, complete, and compliant including documents for new products.
Ensure compliance to training requirements is maintained.
Represent Quality at new product project meetings.
What you need to apply:
Bachelor’s degree in relevant science or engineering, plus one years’ relevant experience.
3 years plus experience working in a highly regulated combination product/medical device / pharma manufacturing environment.
Experience of validating/testing computer systems together with good knowledge of compliance good practise (i.e., GAMP5, 21 CFR Part 11, EU Annex 11 and GxPs).
Experience of production and laboratory systems beneficial. Knowledge around MES, SAP, Plant Data Historian, Metrology Instruments and associated software.
Experience of IT infrastructure qualification as per regulatory requirements beneficial.
Experience with computer controlled equipment automation systems and Human Machine interphases beneficial.
