- The Manufacturing Compliance specialist will support the Manufacturing Compliance Lead in the support of GMP compliance within the manufacturing department.
- The initial focus of the group is to set-up an internal compliance programme encompassing self-inspection, management of executed documents (Batch records, logbooks and SOP's) and defining metrics and reporting systems for highlighting issues and an escalation process for same.
- The role will include the investigation and co-ordination of deviations, CAPA's, change controls and procedural updates and the overall tracking and reporting of their status.
- An expertise in Trackwise is essential.
- Co-ordinate and organise product change-over activities, and support the general GMP needs of the manufacturing floor staff by being an available GMP resource during shift changes and staff meetings. This position involves interaction with cross-functional departments and a close relationship with Quality.
- Key factors in the function of this position are flexibility, good organization, having excellent time management, solid tracking and follow up, and being self motivated to make continual progress with minimal supervision and no need for reminders.
- BA or BS in a technical discipline
- 1+ years in a GMP regulated environment, with exhibited knowledge or proficiency in a compliance or quality role.
- Experience leading and implementing projects Demonstrated ability to influence peers and teams with no direct reporting lines.
- Ability to speak, present data, and defend approaches in front of a variety of audiences.
- Organizational skills to contribute to department and cross-functional projects Familiarity with FDA & European GMP's and regulatory requirements, guidelines, and recommendations.
- Strong proficiency with Trackwise.
- Technical writing must be at a high level with proficient spelling, grammar, and typing skills preferred.
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