Assistant Manager
Intas Pharmaceuticals Ltd. · Ahmedabad · onsite · Posted 40d ago
Undisclosed3–8 yrsfulltimeSourced from
About a minute. You'll make an account on the way through.
About this role
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.
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.
Sourced from naukri
Skills
PRACPSUSALabelingGmp CompliancepsurSPCPIL
About Intas Pharmaceuticals
Intas Pharmaceuticals Ltd.
Pharma
17.4k+
employees
1977
49 years old
Ahmedabad, Gujarat
India
₹5.8L PA avg
Avg at Intas Pharmaceuticals
About
Intas is one of the leading multinational pharmaceutical formulation development, manufacturing, and marketing organization in the world.
Industries
PharmaBiotech & Life sciences
Employee ratings
10 reviews
4.1/ 5
Culture
2.5
Career growth
2.4
Work-life
2.4
Employees rate it well for
Job Security41Overall Company41
Find them on