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Job Details

Senior Software Tester - Validation - Compliance

Company: Elevate Direct Ltd
Location: Limerick, Ireland
Reference: PH-AL-STJJ-040117
Closing Date: 04 Feb 17
Type: Contract
Salary (£): Competitive
Benefits:

Job Summary:

Senior Software Tester / Limerick, Ireland /12 Months Contract / Up To 35 EUR Per Hr

Requirements:

Senior Software Tester / Limerick, Ireland /12 Months Contract / Up To 35 EUR Per Hr

The Role

• Identification and root cause analysis of potential bugs.

• Participate in Troubleshooting.

• Manage defects through a defect tracking system.

• Conduct validation activities in compliance with US and EU regulations, global procedures and EHS requirements.

• Work with the various departments / groups in development and execution of validation activities associated with new system or System upgrades.

• Provide input into all project phases i.e. from design through to the commissioning and qualification execution phases of the project.

• Prioritize qualification activities in line with the project schedules and business needs.

• Develop Validation Documentation to support new process/product introductions and existing business continuity and process improvement requirements

• Execute qualification protocols as required including risk assessments and regulatory reviews.

• Resolve and assist in the closure of deviations initiated during qualification execution.

• Complete 21 CFR Part 11 and Annex 11 Assessments

• Implementation and co-ordination of the change control process, review change controls for validation impact, promotes timely approval of all supporting documentation.

• Generate SOP’s / other documentation as applicable.

• Validation representative at daily project management meetings, weekly change control and team meetings.

• Work with all departments in ensuring operational effectiveness and developing product Quality for business continuity and process / product introductions.

• Proven track record in development / execution of Validation programs in areas of Systems

• Run / Manage complaint investigation and resolution of same.

 

The Company

Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.

This job with Johnson & Johnson is a temporary assignment and is being managed by Kelly Services on behalf of Johnson & Johnson. Successful candidates will be placed at the Johnson & Johnson assignment and managed by Kelly Services

 

If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.

Apply for this job: Senior Software Tester - Validation - Compliance

Contact Information:

Address:  Head Office
138 Southwark St, London 
SE1 0SW
England
Tel:  0207 928 2519
Website:  Visit Our Web Site

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