I/C - MS&T / Digitization

Darwinbox Digital Solutions Pvt. Ltd.; Ahmedabad District; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Zydus Lifesciences seeks an Associate Manager to review validation deliverables for centralized GxP software and oversee change controls, deviations, and CAPA. The role involves coordinating training on cGMP trends and ensuring compliance with regulatory requirements across sites.

The incumbent will review computerized systems documents, support IT compliance, and assist in regulatory audit preparations, contributing to robust quality and manufacturing excellence.

Qualifications

• Review validation deliverables for centralized GxP software.
• Review change controls, deviations and CAPA for centralized GxP software.
• Coordinate and conduct internal/external training on cGMP trends and policies.
• Review computerized system documents against procedures and regulatory requirements.
• Ensure IT compliance at sites including SOPs, User Access and network/datacenter quals.
• Perform onsite verification of CAPA/Informatics/Quality Intelligence for computerized systems.
• Support regulatory audit preparation.
• Provide resolution for queries on computerized systems.
• Identify emerging cGMP requirements for computerized systems and implement.

Responsibilities

• Review validation deliverables of centralized GxP software.
• Review change controls, deviations and CAPA related to centralized GxP software.
• Coordinate and conduct training programs/workshops on cGMP trends and policies.

Skills

Software validation

Change controls

CAPA

Training programs

Regulatory audits

IT compliance

Education

M.Pharm

Job description

Manufacturing-formulation-sez- Oncology, Ahmedabad, Gujarat, India

10 - 15 Years

Job Description

ZTMP – REQUEST FORMAT

BU : BU PARENTERAL OPERATIONS -MANUFACTURING

Basic Details:

Position : 60069231

Designation : Associate Manager

Department : Parenteral Quality

Location : ZLL-SEZ Oncology Injectable (Alidac)

Noof Posts : 1

Role : AssociateManager

NeevLevel : 1

Details : Replacement

Positioncode : 60069231

Key Job Description: (Not more than 5 points in 6 lines)

Job Purpose

• To review software validation deliverables of centralizedGxP software
• To review change controls, Deviation and CAPA of centralizedGxP software
• To coordinate and conduct training programs and workshop(internal and external) on current cGMP trend, central quality policy, standardpractice and directive as and when required.
• To review computerized systems documents with respect toestablished procedures and current regulatory requirements to assist site userfor compliance
• To ensure shop floor IT compliances at sites such ascompliance of IT Standard Operating Procedure, User Access Management, Datacenter Qualification and Network Qualification
• To perform onsite verification of Global CAPA/Informatics/Quality Intelligence points for computerized system
• To Provide support to the sites for Regulatory Auditpreparation
• To Provide resolution for queries related to computerizedsystem
• To proactively identify emerging cGMP requirement withrespect to computerized system and implementation as and when required.
• To perform gap assessment related to Computerized systemwith respect to regulatory guideline, US FDA 483 form, USFDA warning letter

Qualification : M.Pharm

Years of Experience : 10 to15 Years

Job Snapshot

Updated Date

23-09-2026

Job ID

JOB11136

Division

Corporate Parenteral

Location

Location Manufacturing-formulation-sez- Oncology, Ahmedabad, Gujarat, India

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.