Ensure a safe working environment for the laboratory through participating or issuing safety risk assessment for product specific methods, or techniques or material and performing 6S inspection.
Lead or participate in investigation arising from laboratory investigation, incidents and accurately assess the impact of the failure so as to make appropriate recommendations remedial or CAPA actions for follow-up
Own and support Involve in the approving initiation and progression of change that may have an impact on product quality, validation, and/or cGMP compliance. This may require assessment of testing requirement, co-ordinate testing of samples and comment on change documentation and ensure closure of change and change actions. Upon completion, review and ensure closure of changes.
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Ensure a safe working environment for the laboratory through participating or issuing safety risk assessment for product specific methods, or techniques or material and performing 6S inspection.
Lead or participate in investigation arising from laboratory investigation, incidents and accurately assess the impact of the failure so as to make appropriate recommendations remedial or CAPA actions for follow-up
Own and support Involve in the approving initiation and progression of change that may have an impact on product quality, validation, and/or cGMP compliance. This may require assessment of testing requirement, co-ordinate testing of samples and comment on change documentation and ensure closure of change and change actions. Upon completion, review and ensure closure of changes.
...