Quality Control

Connecticut  ‐ Onsite
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Keywords

Description

Responsible for leading the Quality Control and coordinating all activities related to managing action planning, execution and data remediation. Role may include assessing significance of issues and initiating immediate action, assisting with Root Cause Analysis, action plans, developing Corrective and Preventative Actions (CAPA) as needed and documenting suspected and/or significant deviations through the Quality Management System. Will interact with a diverse range of stakeholders both internally and externally. May be some remote work involved.

Primary Duties:
  • QC action plan management
  • Forming rapid response teams
  • Supporting audits and inspections
  • Supporting associated quality workstreams
  • Determine significance of issues (with project teams), follow-up as needed
  • Participating in meetings with external vendor QC teams within timelines specified
  • Participating in meetings with internal stakeholders within timelines specified
  • Assisting Root Cause Analysis as necessary
  • Ensuring appropriate actions assigned and progressed to completion
  • Updating the database as necessary for CAPA tracking
  • Ensuring all documentation is filed appropriately
SKILLS:

Education:
  • Degree in a field related to drug development or business.
  • Advanced/in-depth knowledge which may include quality audit, quality management, inspection readiness, regulatory requirements, GCP, quality and compliance assessments, CAPA Management, continuous improvement methodology, root cause analysis.
  • Knowledge of clinical trials operational processes and systems which may include study management, data management, programming, reporting, project management and medical writing.
Prior Experience Preferred:
  • Ability to collaborate successfully with internal and external partners; strong interpersonal skills and ability to build and maintain excellent working relationships
  • Experience of leading global initiatives or project teams
  • Knowledge of quality/regulatory requirements across a range of different countries
  • Ability to influence a range of global stakeholders.
  • Excellent communication skills that are adaptable to meet the needs of the audience.
  • Record of achievement and delivery for goals.
  • Ability to balance and prioritize a varied and demanding workload
  • Takes initiative to work independently and sets own work agenda
Required Competencies:
  • ICH GCP, and Regulatory obligations
  • Quality and compliance management, 4-7 years of Quality Control experience
  • Project/initiative coordination and management skills
  • Root Cause Analysis
  • Data Management and systems skills
  • Knowledge of programming and medical writing
  • Inspection/inspection readiness
  • Audit, and compliance
  • CI/RCA skill and experience
  • Experience leading cross-line global initiatives
  • Ability to perform root cause analysis for quality related process improvement.
  • Ability to effectively project manage multiple tasks, lead QC teams, progress delivery of actions
Start date
n.a
From
Synectics
Published at
21.11.2013
Project ID:
630668
Contract type
Freelance
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