QA Controlled Docs Associate

Bengaluru - India

Monthly Salary: Not Disclosed

Posted on: 14 hours ago

Vacancies: 1 Vacancy

Job Summary

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.
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.

Qualifications (Minimum Required):

6 - 8 years in regulatory environment (experience in GXP roles).
Fortrea may consider relevant and equivalent experience in lieu of educational requirements.

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.

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.

Required Experience:

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 accord...