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 recent 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

Job Snapshot

Updated Date

10-09-2026

Job ID

JOB10660

Division

CENTRAL QUALITY

Location

Corporate Office|Corp. Office, Ahmedabad, Gujarat, India ..+ 1

Experience

15 - 20 Years

Employee Type

C-C8-Confirmed-HO Executive

📌 Manager/ Senior Manager - DQA (Ahmedabad)
🏢 Zydus Lifesciences
📍 Ahmedabad