QA Control Documents Senior Coordinator

2 weeks ago

Mumbai, Maharashtra, India Fortrea Full time ₹ 12,00,000 - ₹ 36,00,000 per year

Summary Of Responsibilities

  • 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.
  • Assist with implementation of new/revised processes and procedures.
  • 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.
  • All other duties as needed or assigned.

Qualifications (Minimum Required)

  • 3 years in regulatory environment (experience in GXP roles).
  • Demonstrated ability to plan, prioritize, organize and communicate effectively.
  • Demonstrated ability to pay attention to detail.
  • Strong analytical skills.
  • Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

Experience (Minimum Required)

  • 3 years in regulatory environment (experience in GXP roles).
  • 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.

Physical Demands/Work Environment

  • Tasks involve sitting in front of a terminal for many hours during the working day.

Learn more about our EEO & Accommodations request here.

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