CAPA Manager
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Job Location:
Mexico City - Mexico
Monthly Salary:
Not Disclosed
Posted on:
16 hours ago
Vacancies:
1 Vacancy
Job Summary
Responsibilities:
Services rendered will adhere to applicable SOPs WIs policies local regulatory requirements ICH-GCP etc.
Main responsibilities will include but are not limited to:
Act as process and system SME for the nonconformance and CAPA process and business/system requirements
Assist the Investigation Owner (IO) in the application of structured problemsolving methodologies in Root Cause Analysis (RCA) investigations (Fishbone 5 Whys etc) independently or in support of the Root Cause Investigation team
Coach the Investigation Owner in understanding their end-to-end accountability of the entire CAPA process
Develop and maintain proficiency in the TrackWise ETS QEM system
Work with the organization to identify resources to support RCA investigations and resulting actions
Provide assistance to the record owner to ensure process requirements are met
Monitor nonconformance and CAPA deliverables / timelines for functional area by running reports communicating upcoming deadlines to record owners and escalating concerns to management as appropriate to actively drive compliance
Act as a liaison between the record owner and the quality leader; the record owner and the Root Cause Analysis group; the record owner and the TrackWise central entry team.
Escalate any issues as needed to the BRQC CAPA Review Board
Raise any process or system questions or concerns to the CAPA Champions Community of Practice
Manage requests for assistance from the TrackWise central data entry team on behalf of the IO
Education and Experience Requirements/Qualifications:
A minimum of a Bachelors degree in Science (BSc) or Arts (BA) or 68 years of relevant experience is required.
At least 6 years of experience in the pharmaceutical industry with 34 years of GxP experience in clinical research development or quality assurance.
Experience in Quality Control and Compliance Quality Assurance CAPA processes and/or Root Cause Analysis.
Knowledge of the overall drug development process.
Strong understanding of business processes and practices including SOPs governing clinical research activities.
Experience in quality assurance activities such as audits of clinical investigative sites systems and vendors and audits of regulatory submissions.
Ability to translate data into actionable insights and develop executable strategies.
Strong conflict resolution negotiation and stakeholder motivation skills.
Ability to independently plan organize and manage tasks.
IQVIA is a leading global provider of clinical research services commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at
Required Experience:
Manager
Key Skills
- Restaurant Experience
- Customer Service
- Employee Evaluation
- Management Experience
- Math
- Employment & Labor Law
- Sanitation
- Leadership Experience
- P&L Management
- Mentoring
- Supervising Experience
- Restaurant Management
About Company
IQVIA is the Human Data Science Company™. We are inspired by the industry we serve and provide solutions that enable life sciences companies to innovate with confidence, maximize opportunities and ultimately drive human health outcomes forward. Our approach is Human Data Science – a d ... View more
