Assistant Manager - DQA

Sr. No.

Responsibilities

• 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