Manufacturing Compliance Specialist s required for a Cork based Biopharmaceutical company. The site 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. The site is currently moving from commissioning into full scale commercial operations. This is an opportunity to work in a company that is innovative (ranked 10th most innovative by Forbes) and recognized globally as one of the fastest companies to get medicines to market.
This role offers you a chance 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.
The Manufacturing Compliance Specialist will:
o 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.
o 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.
o 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.
o 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 Specialist will require:
o BA or BS in a technical discipline (physical or biological sciences preferred but not required)
o 3-5 years xperience in a GMP regulated environment, with exhibited knowledge or proficiency in a compliance or quality role.
o Experience leading and implementing projects 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 Familiarity with FDA & European GMP’s and regulatory requirements, guidelines, and recommendations.
o Strong proficiency with Trackwise.
o Technical writing must be at a high level with proficient spelling, grammar, and typing skills preferred.
Call Mairead in LSC on 0214777 329 to discuss this Manufacturing Compliance Specialist role in more detail or apply directly via this advert