Manager/ Senior Manager - DQA

Zydus Healthcare Limited; Ahmedabad District; On-site; INR 2,500,000 - 4,000,000; Full time

Job summary

Zydus Lifesciences Corporate Office in Ahmedabad invites an experienced QuALITY role to oversee analytical method reviews, validation reports and QbD compliance across development sites. The incumbent will ensure timely approvals, manage change controls, and support regulatory filings for multiple markets, reporting to the Central Quality division.

With 15-20 years of experience, you will ensure scientific justification in risk assessments and oversee impurity compliance reviews, contributing to

Responsibilities

• To ensure and facilitate timely review and approval of analytical method validation protocols, reports, and method development reports.
• Review and approval of new and revised specifications and standard test procedures for drug substance and drug product.
• Review the change control forms.
• Review and approval of documents like study protocol and report, DMF, strategy notes, decision notes.
• Review QbD compliance during product development across PTC sites.
• Prepare, review and approve the required Quality Policies, Quality directives and Procedures of Development Quality assurance.
• Ensure the justifications provided in the risk assessment during the Product/Analytical development are scientifically justified.
• Participation and tracking of Regulatory deficiencies and response Review and approval.
• Provide support for Regulatory filing for all markets.
• To Review Elemental Impurity compliance reports
• To Review Nitrosamine Impurity compliance reports
• Any other work allotted by Head DQA

Job description

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

15 - 20 Years

Job Description

Sr. No.

Job Responsibilities

1

Toensure and facilitate for the timely Review and approval of Analytical methodvalidation Protocols, Reports and Method development reports.

2

Reviewand approval of new and revised specification and standard test procedure ofdrug substance and drug product initiated by PTC.

3

Toreview thechange control form.

4

ToReview and approval of documents like study protocol and report, DMF,Strategy Notes, Decision notes.

5

Toreview QbD Compliance during the product development across PTC sites.

6

Toprepare, review and approval of the required Quality Policies, Qualitydirective and Procedures of Development Quality assurance.

7

Toensure the justifications provided in the risk assessment during theProduct/Analytical development was scientifically justified.

8

Participationand tracking of Regulatory deficiencies and response Review and approval.

9

Toprovide support for Regulatory filling for all markets.

10

ToReview Elemental Impurity compliance reports

11

ToReview Nitrosamine Impurity compliance reports

12

Anyother work allotted by Head DQA

Job Snapshot

Updated Date

10-09-2026

Job ID

JOB10660

Division

CENTRAL QUALITY

Location

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

At Zydus Lifesciences, w e nurture a culture of innovation, excellence, and inclusivity , driving meaningful advancement in the pharmaceutical and healthcare industries. Fueled by creativity , we constantly exploring new ways to improve patient care and expand healthcare accessibility.

Our commitment to a positive and empowering work environment has earned us recognition as one of India's Best Workplaces in Biotechnology & Pharmaceuticals.