12 Sep
|
Intas
|
Ahmedabad
1. Evaluation of change control request receiving from all the cross-functional teams.
2. Co-ordinating with the all the cross-functional teams to arrange the documents as mentioned & generated as per the change control request.
3. Review of all documents required for variation filing ensuring its accuracy & adequacy.
4. Timely highlight the concerns /issues/non-compliance to the reporting manager
5. Submission, review & Monitoring the submission of Type IAIN, IA, IB and II European variations of solid oral dosage forms to regulatory agencies.
6. Submission, review & Monitoring of Regulatory variation deficiencies.
7. Monitoring the variation approvals.
8. To carry out additional activities related to the regulatory department as and when required.
9. To follow GMP Compliance and procedure as per the respective SOPs.
📌 Assistant Manager (Ahmedabad)
🏢 Intas
📍 Ahmedabad