ZTMP – REQUEST FORMAT

Name : Isha Naik

BU : BU PARENTERAL OPERATIONS - MANUFACTURING

Place : ZLL-SEZ Oncology Injectable, SEZ, Matoda, Ahmedabad.

Email Id : [email protected]

Basic Details:

Position : 60069231

Designation : Associate Manager

Reports to : CQA Lead

Department : Parenteral Quality

Location : ZLL-SEZ Oncology Injectable (Alidac)

No of Posts : 1

Role : Associate Manager

Neev Level : 1

Details : Replacement

Position code : 60069231

Position Name : I/C - MS&T; / Digitization

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

Job Purpose

- To review software validation deliverables of centralized GxP software
- To review change controls, Deviation and CAPA of centralized GxP software
- To coordinate and conduct training programs and workshop (internal and external) on current cGMP trend, central quality policy, standard practice and directive as and when required.

- To review computerized systems documents with respect to established procedures and current regulatory requirements to assist site user for compliance




- To ensure shop floor IT compliances at sites such as compliance of IT Standard Operating Procedure, User Access Management, Data center 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 Audit preparation
- To Provide resolution for queries related to computerized system
- To proactively identify emerging cGMP requirement with respect to computerized system and implementation as and when required.

- To perform gap assessment related to Computerized system with respect to regulatory guideline, US FDA 483 form, USFDA warning letter

Qualification : M.Pharm Years of Experience : 10 to15 Years

Mail your CVs to: [email protected]

Job Snapshot

Updated Date

23-09-2026

Job ID

JOB11136

Division

Corporate Parenteral

Location

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

Experience

10 - 15 Years

Employee Type

P-P8-Probationer-HO Executive

📌 I/C - MS&T / Digitization (Ahmedabad)
🏢 Zydus Lifesciences
📍 Ahmedabad