About the role
Sr. No.
Job Responsibilities
1
To ensure and facilitate for the timely Review and approval of Analytical method validation Protocols, Reports and Method development reports.
2
Review and approval of new and revised specification and standard test procedure of drug substance and drug product initiated by PTC.
3
To review the change control form.
4
To Review and approval of documents like study protocol and report, DMF, Strategy Notes, Decision notes.
5
To review QbD Compliance during the product development across PTC sites.
6
To prepare, review and approval of the required Quality Policies, Quality directive and Procedures of Development Quality assurance.
7
To ensure the justifications provided in the risk assessment during the Product/Analytical development was scientifically justified.
8
Participation and tracking of Regulatory deficiencies and response Review and approval.
9
To provide support for Regulatory filling for all markets.
10
To Review Elemental Impurity compliance reports
11
To Review Nitrosamine Impurity compliance reports
12
Any other work allotted by Head DQA