Executive

Senior Executive-IT

Job Grade

G11B

Function

IT

Sub-function

IT

Manager’s Job Label

Manager

Location:

Dahej

Areas Of Responsibility

• Responsible to maintain of all servers and its related activities, this is also including necessary patch management for all servers. Coordinates with server team for any problem faced to ensure maximum uptime.
• Monitoring, Execution & timely reporting for all the ongoing activities Project at Dahej site.
• Responsible for local administration in all computers and servers at site.
• Supervise, Support and Manage location IT Team of Dahej.
• 21 CFR part 11 Assessment: Assist in 21 CFR part 11 assessments during Computerized Systems selection.
• To prepare, review & approve SOP, related to IT department specifically analytical & Manufacturing system Instrument / Equipment software operating procedures.
• Responsible for Maintain & Secure the Login/Password as “Administrator” of Instrument / Equipment available in QC & MFG system.
• Preparation of necessary Indent / IT requisition and receipt for IT related item
• Perform IT operation related activity according to GSOP & SOP.
• To perform, review & approve Preventive Maintenance of GxP System, Desktop, Laptop, Printers, Server and Network devices etc. As per SOP/GSOP.
• Represent IT at site business forums, meetings etc.
• Represent IT into any regulatory, customer or internal inspection and co-ordinate with site IT or Centralized Team to provide desired inputs / information.
• Co-ordinate with Centralized IT Team, Vendors, Services Providers or Business Functions for resolution of any application, services or functional issues.
• As and when required, To Prepare, Review Documents related to IT department.
• Review and approval of QMS (Deviations, Change Control, CAPA, incidences, investigations etc.) Related to computerized systems.
• Maintain & secure administrator password of QC standalone instruments (e.g. Balances, chambers). Also Synchronize Date & Time of QC balances as per SOP.
• Responsible for Maintain & Secure the Login/Password as “Administrator” of Instrument / Equipment available in QC & MFG system.
• Participation into Qualification & Validation: Perform/ participate into qualification and validation of Manufacturing Automated System including PLCs/ SCADA System from IT for various IT admin roles.
• Review of Qualification / Validation Documents: Review of qualification and validation documents of Manufacturing Automation Systems including PLCs/SCADA Systems from IT Perspective covering 21 CFR Part 11 applicability, ER/ES, User & Role Management, Software Categorization, Audit Trail etc.
• Support on OS: To provide IT admin support on Operating system (OS) of computer Servers, Desktop, Laptops, Industrial PCs, Hand held devices etc.
• Backup Management: To perform the data and program backup and retrieval of Manufacturing Automated systems including PLCs/SCADA Systems as per applicable SOP(s) at site.
• Quality Compliance Systems: To provide Admin support for Computerized systems in Quality systems. Also provide support in Qualification / Validation instrument systems at Dahej site.
• To Perform Software Validation of New Instrument and to Perform challenge test for defined to meet the 21 CFR Part 11 Requirement.
• To Implement system and Software Policies as defined in Individual Instrument / Equipment SOP/GSOP.
• To Perform IT related activities as defined in individual Instrument / Equipment SOP.
• To maintain and secure 21 CFR Part 11 compliance of Instrument/Equipment available in QC.
• Responsible as administrative rights holder for Instrument / Equipment software available in QC.
• To co-ordinate with Corporate IT Department for implementation of laboratory instrument control policy/Media Policy to Ensure 21 CFR compliance.
• Responsible to prepare SOP’s related to backup of Electronic Data generated by laboratory Instrument/Equipment Software’s.
• Responsible to Implement and monitor backup policies including data archival, retrieval and challenges test to archival / retrieval system in timely manner.
• Logical Security verification and Data protection policies of GxP/non-GxP Computerized System as per procedure.
• Monitoring and taking daily back up and maintaining record as per GSOP.
• Backup Media Controlling, maintaining record and Data Center monitoring as per GSOP.

Job Scope

Internal Interactions (within the organization)

Business and Functions

External Interactions (outside the organization)

Vendors

Job Requirements

Educational Qualification

BE, B Tech, BCA, MCA

Specific Certification

Experience

7+

Skill (Functional & Behavioural)

Infra knowledge-Hardware, CSV, compliance, networking, budget management, site management