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.
- Robust 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.

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📌 QA Controlled Docs Associate (Mumbai)
🏢 Fortrea Development India
📍 Mumbai