Excellent opportunity for a Manufacturing Compliance Specialist to work in a state of the art facility, in an innovative Biotechnology company, with excellent career development opportunities and a clear and committed patient focus. Based in Cork this is a high-performing, team based organization that manufactures low volume bulk API for Phase III clinical trials, initial product launch and long term market support. The team on site grow, purify, formulate and bulk fill mammalian cell culture derived APIs for medicines intended for human use.
This is an opportunity to work in a company that is ranked 10th most innovative by Forbes and recognized globally as one of the fastest companies to get medicines to market.
The Manufacturing Compliance Lead is responsible for the support of GMP compliance within the manufacturing department.
The initial focus of the role 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.
In addition 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.
The Manufacturing Compliance Specialist will 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.
The Manufacturing Compliance Lead will be responsible for:
o Set-up an internal Compliance Programme within the manufacturing department.
o Self-Inspection Programme
o Management of GMP Records
o Tracking and Reporting Systems
o Escalation process
o Full understanding of basic cGMP expectations; set a good example in observance of cGMP policies.
o Interact with the Manufacturing floor staff regularly to answer questions related to GMPs and help champion a compliant work environment with a Continuous Improvement Focus
The Manufacturing Compliance Lead will have: •
o BA or BS in a technical discipline (physical or biological sciences preferred but not required) with 4+ years related to pharmaceutical manufacturing
o 8+ years experience in a GMP regulated environment, with exhibited knowledge or proficiency in a compliance or quality role.
o Experience leading and implementing projects
o Demonstrated ability to influence peers and teams with no direct reporting lines.
o Ability to speak, present data, and defend approaches in front of a variety of audiences.
o Organizational skills to contribute to department and cross-functional projects
o Familiarity with FDA & European GMP’s and regulatory requirements, guidelines, and recommendations.
Please contact Regina on 021 4777329 for full details or apply directly through this advert.