GMP Validation Engineer

Sectors:
Chemicals, Inspection & testing labs
Locations:
International
Qualifications:
Not specified
Contract type:
Permanent
Hours:
Full time
Salary description:
Competitive
Specialist areas:
Quality assurance (main), Audit/assessment, Consultancy, Health and safety, Operational improvement, Project management, Risk management
Sub-sectors:
All
Posted:
04/12/2019
Start Date:
09/12/2019
Recruiter:
Michael Bailey Associates - UK Contracts
Job Ref:
806610704

GMP Validation Engineer

Assures the quality of processes and products by performing audits, inspections, tests, defect analysis, trend analysis, programming & troubleshooting inspection equipment, calibration maintenance, and reporting on results of measurement standards. Assures consistent quality of suppliers and production by validating processes; providing documentation from measurement analysis, and helping departments understand the interpretation of collected data.

Responsibilities:
* Development of validation documents (i.a. IQOQ, FAT, SAT, Design Specifications)
* Execution and documentation of Acceptance Tests at Factory (FATs) and at customer site (SATs) and IQOQs at company and/or at customer site
* Cooperation with customers, project team as well as with internal software and hardware development Teams
* Monitoring all project-related activities including completeness of documentation
* Development of test protocols for internal testing and tests on customer site

Qualifications:
* University Degree/equivalent education in System Engineering, Pharmaceutical Technology, Automation, Technical Documentation
* Experience in equipment qualification and validation of computerized systems in the pharmaceutical environment
* Knowledge in pharmaceutical industry, image processing, Track & Trace and experience with coding standards (GS1, Brazil, China) is highly beneficial
* Experience in editorial systems, especially in Cosima Go disired
* Fluent in German & English; further foreign languages are beneficial

Nice to Haves:
* Experience in Track & Trace
* Experience in coding standards (GS1, Brazil, China)

Michael Bailey International is acting as an Employment Agency in relation to this vacancy.

Closing Date:
01/01/2020
Contact Details:
Michael Bailey Associates - UK Contracts
Contact: Isabel Rieger

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