QC Quality Systems Specialist

Desired Skills: change controls,investigations,QC

PE Global is currently recruiting for a QC Quality Systems Specialist on behalf of our client based in North Dublin: 12 month initial contract

The Role
Our Biologics client is seeking to recruit a Senior Specialist, QC Quality Systems (Lead Investigator) on a 12 month initial contract basis, reporting to the QC Shared Services Manager. 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

Interested candidates should submit an updated CV.

Please click the link below to apply, call Audrey on 0214297900 or alternatively send an up-to-date CV to audrey.mccarthy@peglobal.net