I/C - MS&T / Digitization

ZTMP – REQUEST FORMAT
Name : Isha Naik
BU : BU PARENTERAL OPERATIONS -
MANUFACTURING
Place : ZLL-SEZ Oncology Injectable, SEZ,
Matoda, Ahmedabad.
Email Id : Isha.naik@zyduslife.com
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 Job Description: (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 requi

Experience
10 - 15 Years

Employment type
P-P8-Probationer-HO Executive

Work arrangement
No