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About the Role
Description: oSupports and collaborates with the project team for validation efforts right from inception, design build, test and implementation
oInvestigate/troubleshoot validation discrepancies for systems and/or performance processes
oSupport validation activities IQ/OP/PQ
oSupport ethylene oxide requalification activities to meet ISO requirements on time
oCreate change controls and provide assistance in determining root cause for non-conforming events and evaluate CAPAs for effectiveness
oEnsures required processes and procedures are followed to support validation programs and are in compliance with regulations
oCo-operates with all departments through open, candid communication and collaboration
oPrior experience working with ethylene oxide and gamma sterilization processes
oPharmaceutical Industry GMPs. Interpret & Apply ISO 11135, 11137, TIR 15, TIR 28, 11737 and FDA and Country specific guidelines to the
medical devices and surgical.
oInvestigate/troubleshoot validation discrepancies for systems and/or performance processes
oSupport validation activities IQ/OP/PQ
oSupport ethylene oxide requalification activities to meet ISO requirements on time
oCreate change controls and provide assistance in determining root cause for non-conforming events and evaluate CAPAs for effectiveness
oEnsures required processes and procedures are followed to support validation programs and are in compliance with regulations
oCo-operates with all departments through open, candid communication and collaboration
oPrior experience working with ethylene oxide and gamma sterilization processes
oPharmaceutical Industry GMPs. Interpret & Apply ISO 11135, 11137, TIR 15, TIR 28, 11737 and FDA and Country specific guidelines to the
medical devices and surgical.
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