Operations Compliance Officer

2 months ago

Hertfordshire, United Kingdom WALKER COLE INTERNATIONAL LTD Full time

Walker Cole is searching for an Operations Compliance Officer to join a leading Cell and Gene Therapy company based in Hertfordshire.

As an Operations Compliance Officer, you will be required to manage and maintain operational processes, ensuring compliance with key standards and regulatory authorities.

The key responsibilities of an Operations Compliance Officer involve:

- Providing operational oversight within the facility, ensuring that operational procedures and policies are complied with.
- Providing oversight to activities undertaken by the contract cleaning services provider, ensuring that cleaning in all GMP areas comply with quality standards and is executed in adherence to the schedule.
- Ensuring facility log-books are completed and maintained compliantly in accordance with GMP and data integrity principles.
- Performing root cause investigations, GEMBA walks and reviews of existing processes and systems to drive improvement.
- Work with QC, QA, Engineering, Warehouse personnel, Collaborators, suppliers, and services providers to assist in the maintenance of GMP complaint operations as required.
- Take ownership for developing and maintaining a set of Operational KPIs which enables the performance of the department to be measured and drives continuous improvement.
- Managing Quality Records (Non-Conformances, Change Controls, CAPAs) and LIRs, ensuring that they are executed in a timely manner.

A successful Operations Compliance Officer will have:

- Experience working in pharmaceutical manufacturing environment fulfilling an operational role.
- Experience of scheduling in a production or equivalent environment.

Operations I Scheduling I Planning I Planner I Manufacturing I Quality I Operational I Compliance I Warehouse I KPI

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