Quality Systems Compliance Officer

2 weeks ago

Cambridge, United Kingdom Mundipharma Full time

Help ensure the quality compliance of Mundipharma’s Independent Associated Company (IAC) network by:

- Ensuring the Quality Management System remains in a State of Control and opportunities for improvement are continuously identified and acted upon
- On behalf of Mundipharma’s Independent Associated Company (IAC) network
- Registering various Quality and Security incidents and route these for completion
- Performing temperature excursion assessments and route these for completion

Key Responsibility

1 Supports the product complaints process by:

- Logging and responding to product complaints, distribution complaints, and distribution temperature excursion incidents by liaising with other departments and IACs
- Performing risk assessments for temperature excursion incidents
- Reviewing and approving distribution complaints/temperature excursions

to ensure Mundipharma’s compliance posture and effective and efficient operations are maintained and advanced.

2 Supports quality systems processes by:

- Ensuring effective change control and CAPA processes and procedures are in place to ensure compliance with the Mundipharma Quality Framework and policies, cGMP and local regulatory requirements
- Implementing continuous improvements to maintain and advance Mundipharma’s compliance posture and effective and efficient operations.
- Ensuring change controls and CAPAs are executed in a timely fashion to maintain the pharmaceutical quality system’s state of control
- Supporting creation of local Annual Product Quality Review reports to monitor whether the product and processes remain in a state of control
- Supporting qualification and maintenance of service providers and customers to ensure Supplier and Customer Quality Assurance

3 Assists with quality data trend analysis by employing data analytics and compiling reports for management quality reviews and product quality reviews to monitor whether the pharmaceutical quality system, product, and processes are in a state of control.

4 Supports the inspection readiness program by
- Participating in pre-audit, audit execution and audit response activities for internal audits in support of the company self-inspection program
- Maintaining applicable MIA/WDA/API licenses and site master files
- Supporting the hosting of external inspections and customers audits by coordinating logistics and participating in pre-audit, audit execution and audit response activities.

to maintain and advance Mundipharma’s compliance posture.

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