Process Engineer/Technician

DUTIES:
Qualifying quality issue management
Forming qualifying quality issue Team
Determine significance of the issues (with team), follow-up as needed
Arranging meetings with teams within timelines specified
Documenting meeting outcomes in meeting minutes or other
Facilitating root cause analysis and producing outputs
Ensuring appropriate actions assigned and progressed to completion
Updating the appropriate database
Ensuring all documentation is filed appropriately

SKILLS:

QUALIFICATIONS:
Quality related experience including familiarity with: regulatory obligations, quality and compliance management, quality control, project/initiative coordination and management skills, root cause analysis
Experienced in quality areas: audit, inspection, compliance and inspection readiness fields
Project management skills
Knowledge of ICH GCP and regulations in order to assess GCP situations and appropriate actions
Ability to lead cross-line global initiatives or root cause analysis for quality related process improvement
Understanding of clinical trials
Ability to work successfully with internal and external partners; strong interpersonal skills and ability to build and maintain excellent working relationships across lines in a Matrix organization
Experience leading global initiatives or project teams. Appreciation of diverse needs of different regulatory requirements of different sites and countries.
Knowledge of quality requirements across a range of different countries
Strong influencing skills with ability to influence a broad range of global stakeholders.
Excellent communication skills adaptable to meet the needs of diverse stakeholder groups, internal and external.
Record of achievement and delivery for personal and team goals.
Ability to balance and prioritize a diverse and demanding workload.
Works independently and proactively set own work agenda with minimum guidance
Biopharmaceutical and manufacturing experience preferred

TRAINING/EDUCATION:
Degree in discipline related to drug development or business. Advanced/in-depth knowledge which may include quality audit, quality management, inspection readiness, quality and compliance assessments, continuous improvement methodology, root cause analysis. Knowledge of clinical trials operational processes and systems which may include study management, data management, reporting, and project management.