Role Title: Senior QC Quality System Specialist

Role Type: Contract

Location: North Dublin

We are seeking to recruit a Senior Specialist, QC Quality Systems for a Biopharmaceutical Manufacturer in Dublin 15. The QC Quality Systems Senior Specialist will be part of a team who are responsible for supporting the Quality Control team with Investigations and Change Controls

Key Duties and Responsibilities:

• Lead and manage QC Investigations assigned

• Facilitate root cause analysis and problem solving sessions

• Complete the generation of associated investigation reports

• Determine and create CAPA’s, Effectiveness Reviews, and Supplemental Tasks as required

• Present investigations at IRB to senior management

• Leading and coordinating the initiation, implementation, and closure of QC Change Controls

• Ensuring the timely completion of all activities related to these quality systems

• Collation of metrics/KPI’s and generation of associated dashboard read-out

• Communication with local and global stakeholders

• Lead huddles, meetings, conference calls and provide read-outs

• Participate in the OpEx strategy and support process improvements

• Participate in internal and external audits

• Support additional QC shared services activities, as required

Qualifications, Knowledge and Skills Required:

• Proficiency in communication and collaboration at a variety of levels

• Proven success working well in a team environment with flexibility to react to changing business needs

• Demonstrated problem solving, project management ability

• Excellent time management and organizational skills

• Excellent technical writing skills

• Previous investigations experience is an asset.

• Ability to research and have an excellent understanding of new areas/tasks/assays under investigation promptly

• Education minimum of a B.Sc. Biochemistry or related discipline

• At least 3 years’ experience, in a GMP laboratory setting ideally within a biologics laboratory

• A minimum of 1 years’ experience with demonstrated effectiveness using quality systems (investigations/change controls – Trackwise/Infinity) in a FDA and EMA regulated environment

• Knowledge of biologics QC testing (Separations, Bioanalytical, Microbiology, Raw Materials and Stability testing) is desirable