Senior Executive-Plant IT Operation

Job Title:

Sr. Executive

Job Grade (refer to JE)

G11B

Function:

Plant IT Operation

Sub-function:

QI Support

Manager’s Job Label:

Location Head IT

Skip Level Manager’s Label:

Cluster Head IT

Function Head Title:

Head - IT Manufacturing Operations

Location:

Dewas

No. of Direct Reports (if any)

02 (off roll Team)

Business Unit:

Dewas API

Job Summary

Responsible for IT related activity for SGO & API Dewas. Define strategy in line with Sun Pharma compliance, product quality management objectives and regulatory requirements. Proactively assess quality issues in quality control labs of the site and ensure compliance in quality control labs of Sun Global Operation Dewas. Support for all time readiness of the site QC for any internal and regulatory agency audits \ inspections at any given point of time.

· To prepare and review standard operating procedures associated with the planning, development and operation of IT related systems.

· To maintain software related data of Laboratory Instrument / Equipment’s as an Application & system Administrator.

· To perform activities like creation / modification / Disable / Re-activation of User Account(s) and

assigning of privileges for both windows & application.

· To prepare, review configuration specification & Computerized System Administration Protocol documents.

· To maintain User Account Request / record of user(s) for both windows & application.

· To perform the activities of Server software like: Project creation, template migrations,

Archival / backup of soft data, Restore projects.

· To perform the activities of standalone / Non-Domain Laboratory instruments software’s like

Archival / backup, restoration etc.

· To control and maintain the Password of Analytical Balances, pH meter and Stability chambers (HMI) used in the Quality Control Laboratory.

· To prepare validation / Review documents such user as requirement specifications, validation plans, test plans, summary test result and final validation reports.

· IT activity related to IQ/OQ/PQ and configuration policies for standalone / Non-Domain Laboratory instrument software.

· To coordinate and verify that all validation activities and documents comply with applicable regulations and internal procedures at all locations.

· To follow and comply timeline adherence with the new IT project plan and CSV compliance.

· Ensure timely completion of Qualification of new laboratory instrument and its associated activities in Quality Control labs in Dewas location.

· Coordinate with concern stake holders and vendors for timely completion to QC IT and instrumentation related activities. · Ensure integrity, accuracy and adequacy of the IT activity to be performed. · Responsible for initiation of CCR and handling of Deviation, Investigation, CAPA in QMS System with respect to IT activities. · Perform other activity as and when required. · Accountable for all activities related to QC IT like - instruments, GLP and Qualification.

Areas of Responsibility

• QI Support
• QMS
• Validation
• Backup Management
• Compliance Documentation 
• Team Management off roll Engineers

Travel Estimate

Job Scope

Internal Interactions (within the organization)

External Interactions (outside the organization)

Geographical Scope

Financial Accountability (cost/revenue with exclusive authority)

Job Requirements

Educational Qualification

Any Graduate with IT certification

Specific Certification

IT

Experience

10-12 years

Skill (Functional & Behavioural):

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