Job Description
Job Description
Full-Time
Cambridge, MA
Salary: $60-70,000/year
OBJECTIVES:
- Performs review, coding, and entry of deviation, quality investigation, inspection, change control and audit report findings, Corrective and Preventative Actions (CAPAs), and other relevant information
- Ensure Trackwise Quality Management System is maintained, that relevant data are entered timely, consistently and accurately
- Support administrative activities in inspections and business partner audits of Takeda
- Ensures all records are current.
- Assists team with support of global functions of GPSE, GMA and GRA (excluding CMC) in the implementation of Takeda Quality Management System (QMS) methodology, infrastructure and tools
- Act as System Expert
RESPONSIBILITIES:
- Participates, with supervision, on GCP/GVP related projects initiated by internal stakeholders
- Maintains, and/or updates tracking tools maintained by the QA department.
- Trackwise data entry for audits, investigations, change control that impact the Pharmacovigilance and Medical systems
- Generate reports from Trackwise and provide these reports in
- Track compliance data
- Assist in the
- Manage data in Trackwise, spreadsheets and reports
- Keep records and reports up to date
- Keep records for training, budget, expenses
- Organize and schedule meetings and events
- Assists with the maintenance of risk prioritization tools
- Ensures contract auditors’ qualification files are kept up to date
- Ensures all audits records are kept up to date and that requested dataset(s) are provided to management as requested
- Contributes to list of inspections confirmed and projected
- Provide data, as requested
- Provide feedback on Trackwise performance
- Ensure all inspection and on-site audit related documentation is completed and filed accordingly and that are associated records are up to date.
- Ensures all associated documentation is kept up to date, ensuring items are filed appropriately
- Develops/provides reports/data to stakeholders, as requested
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS
Required:
- BSc in a scientific or allied health/medical field (or equivalent degree).
- 1-2 years of relevant work experience.
- Basic knowledge of pharmaceutical development.
Preferred:
- Experience in quality management systems (e.g., Trackwise) an advantage.
- Additional language skills a plus.
Company DescriptionA great company doing groundbreaking and important work with a great reputation in the industry!
Company Description
A great company doing groundbreaking and important work with a great reputation in the industry!