Fortrea

QA Controlled Docs Associate

Fortrea

full-time

Posted on:

Location Type: Office

Location: Bangalore • India

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About the role

  • Follow applicable departmental Standard Operating Procedures and Work Instructions
  • Complete required trainings according to required timelines
  • Administer controlled documents ensuring availability to the end user
  • Track and report metrics as determined by management according to required timelines
  • Ability to participate in process improvement initiatives and assist with implementation of new/revised processes and procedures
  • Ability to train others using developed materials
  • Demonstrated ability to communicate effectively
  • Perform checks to ensure quality of work completed
  • Ensure timely escalation and resolution management of issues impacting controlled document release
  • Ensure Regulatory Compliance and Quality Assurance (RC and QA) responsibilities, as indicated in applicable controlled documents, are followed
  • Other duties as needed or assigned

Requirements

  • 6 - 8 years in regulatory environment (experience in GXP roles)
  • Experience (Minimum Required): Veeva (Quality & Clinical)
  • Drafting Change controls and deviations
  • Document management and control
  • Demonstrated ability to plan, prioritize, organize and communicate effectively
  • Demonstrated ability to pay attention to detail
  • Strong interpersonal skills with ability to work well with others
  • Ability to deliver consistent high quality of work
  • Ability to use computer and departmental tools
  • Ability to participate in process improvement initiatives
  • Ability to facilitate meetings
Benefits
  • Health insurance
  • Professional development opportunities
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory compliancequality assurancedocument managementchange controldeviation managementprocess improvementmetrics trackingtraining developmentattention to detailGXP experience
Soft Skills
effective communicationinterpersonal skillsplanningprioritizationorganizationproblem resolutionteam collaborationfacilitationtraining othersquality focus