A QC Compliance Associate is required for our leading edge biotech client based in Cork. This company is a high-performing, team based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation are key role requirements, as well as excellent organizational skills.
The QC Compliance Specialist will co-ordinate and organise and support the general GMP needs of the QC staff by being an available GMP resource. This position involves interaction with cross-functional departments and a close relationship with Quality Assurance.
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 initial focus of the group is to set-up an internal compliance programme encompassing self-inspection, management of executed documents (test 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 LIR’s, CAPA’s, change controls and procedural updates and the overall tracking and reporting of their status. An expertise in Trackwise is essential.
As QC Compliance Specialist you will:
oSupport QC Lab Investigation Reports and Deviations.
o Report on the timeliness of compliance to set timelines on LIR’s, Deviations, Quality Events, Material Incidents, CAPAs, and Effectiveness Checks in Trackwise
o Support the internal Compliance Programme within the QC department.
o Self-Inspection Programme
o Management of GMP Records
o Tracking and Reporting Systems
o Full understanding of basic cGMP expectations; set a good example in observance of cGMP policies.
o Interact with the QC staff regularly to answer questions related to GMPs and help champion a compliant work environment with a Continuous Improvement Focus
o Lead Inspection Readiness efforts for QC
o Lead and Participate in Self-inspections and Compliance walk-throughs of QC.
o Managing Change Requests (CRs)
o Work with QC staff and QA Change Control to contribute to comprehensive implementation plans for CRs
As QC Compliance Specialist you 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 5+ 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
For full details on this role please contact Kathy or apply directly through this advert.