Compliance Specialist ( Quality ) – Pharma MNC – Mumbai

You will be responsible for:

-Ensuring license non-compliances as identified through already established Compliance processes are addressed within a pre-defined time frame based on risk.
-Performing Compliance review of new and revised critical Module 3 documents as compiled by Regulatory, prior to submission.

-Approving Quality Risk Assessments as written by License Compliance team.
-Liaising with Regulatory routinely to ensure submission priorities are aligned and quality critical submissions are prioritised.
-Reviewing and approving critical Module 3 documents written by Regulatory prior to submission to ensure content is CTD compliant.

-You should have extensive GxP knowledge across all dosage forms.

-You should have experience in authoring Module 3 in CTD format.

-You should have extensive knowledge of QMS, specifically change controls and risk assessment, and continuous improvements.