Expert Computer System Validator

5 days ago


Vellore, Tamil Nadu, India beBeeSystemValidation Full time ₹ 1,50,00,000 - ₹ 2,00,00,000

Our team is seeking a highly skilled Computer System Validation Specialist to join our global workforce.

This role plays a crucial part in ensuring the quality and compliance of our systems.

The successful candidate will be responsible for validating computer systems, including equipment and software, to ensure they meet regulatory requirements.

This includes knowledge of cGMP concepts, FDA/EMA regulations, QSR, 21 CFR Part 820, 21 CFR Part 11, and ISO 9001 Standards.

Apart from that, hands-on experience with EDMS (Electronic Document Management system) & Test Management tools is also required.

We are looking for an individual who can understand recent FDA guidance on transitioning CSV to CSA as well as possess excellent written and oral communication skills.

Ability to work on complex projects with minimal guidance and handle multiple projects simultaneously is essential.



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