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
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