Description
In this critical role you will provide on-the-floor quality oversight for Facilities and Engineering. This position requires close collaboration with cross-functional teams to ensure that all activities within bulk drug substance operations adhere to cGMP and other regulatory requirements.

Key Responsibilities:

+ Ensure facilities equipment materials processes and products comply with cGMP standards and other applicable regulatory requirements.

+ Review and approve work orders and job plans within Maximo.

+ Review logbooks paper-based and electronic particle-generating forms pest control sighting forms and periodic pest control monthly/quarterly reports RT reports and other GMP documentation.

+ Review and approve Manufacturing Execution System MES records including EBRs and ESPs.

+ Handling of reject materials

+ Review/Approve Delta V Audit Trail entries


Job Type & Location
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