Ref: Compliance Exec
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MAIN PURPOSE OF ROLE:
The Quality Compliance Team within the Quality Department is responsible for ensuring Contract Manufacturing Organisations (CMOs) are provided with current Marketing Authorization information and ensuring that CMOs comply with this information and pharmacopoeial requirements.
This role ensures processes and procedures are in place and are adhered to, to ensure compliance with registered information and pharmacopeial requirements by:
Reviewing master documents from CMOs against the current registration and pharmacopoeial requirements within agreed timeline
Ensuring any remediation actions are completed within agreed timelines
The Compliance Executive has a cross-functional role working closely with Regulatory Affairs, Technical, Operations projects, other Quality functions and CMOs to ensure the above is achieved.