QA Controlled Docs Sr Coordinator

3 - 7 years

0 Lacs

Posted:1 week ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As a Regulatory Compliance Specialist at the company, your role will involve following applicable departmental Standard Operating Procedures and Work Instructions. You will be responsible for completing required trainings as per specified timelines and administering controlled documents to ensure their availability to end users. Tracking and reporting metrics determined by management, assisting in the implementation of new/revised processes and procedures, and ensuring timely escalation and resolution management of issues impacting controlled document release will be crucial aspects of your responsibilities. Additionally, you are expected to demonstrate effective communication skills, perform quality checks on work completed, and adhere to Regulatory Compliance and Quality Assurance responsibilities outlined in controlled documents. Other duties as necessary or assigned will also be part of your role. Key Responsibilities: - Follow applicable departmental Standard Operating Procedures and Work Instructions - Complete required trainings within specified timelines - Administer controlled documents and ensure availability to end users - Track and report metrics as per management's requirements - Assist in implementing new/revised processes and procedures - Communicate effectively - Perform quality checks on completed work - Ensure timely escalation and resolution management of issues affecting controlled document release - Adhere to Regulatory Compliance and Quality Assurance responsibilities Qualifications Required: - Minimum of 3 years of experience in a regulatory environment, particularly in GXP roles - Demonstrated ability to plan, prioritize, organize, and communicate effectively - Strong analytical skills - Relevant and equivalent experience may be considered in lieu of educational requirements In addition to the above, you must have a minimum of 3 years of experience in a regulatory environment, specifically in GXP roles. Strong interpersonal skills, the ability to work effectively with others, deliver consistently high-quality work, and utilize computer and departmental tools are essential for success in this role. Please note that tasks may involve sitting in front of a terminal for extended periods during the working day. Additionally, you should be comfortable working in 2nd shift hours (2 - 11 PM IST). Learn more about our EEO & Accommodations request to ensure a fair and inclusive work environment.,

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Fortrea logo
Fortrea

Pharmaceuticals

Durham

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