Title:  Team Member - Plant IT

Job Title:

Sr. Executive / Executive

Job Grade

G11B/G12A

Function:

Information Technology

Sub-function:

Quality Informatic /Infra

Location:

Baska 2 Plant (L107)-Gujarat

Job Summary

The Job holder will be responsible to Lead the Quality Informatics Team and maintain software

related data of Laboratory Instrument / Equipment’s as an Application Administrator and perform

the activities of Laboratory instruments and also for Manufacturing System software’s like

Archival / backup, restoration, validation & qualification etc.

Areas Of Responsibility

• Manage and perform Quality Management System like Change Control/Deviation etc.
• 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 documents.
• To prepare and review standard operating procedures associated with the planning, development and
• operation of IT related systems.
• 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 Laboratory instruments software’s like Archival / backup,
• restoration etc.
• To prepare periodic review scheduler and execute periodic review of each instrument accordingly.
• 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 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.
• To monitor and maintain record of Quality Control IT compliance status.
• To support site IT for regulatory compliance.
• Support for handling deviation and CAPA effectiveness related to QC driving them down.
• Accountable for designing/implementing and ensuring compliance to all quality related, Policies, Standards and IT systems at QC of the site.
• Facilitate internal and regulatory agency audits, ensuring that findings from site QC audits are understood, assessed and addressed site wise in a comprehensive manner.

Travel Estimate

Based on the need job holder can travel to other sites.

Job Scope

Internal Interactions (within the organization)

QI and CSV Teams, Business Users, Corporate IT & Plant

Management Teams

External Interactions (outside the organization)

Business Users, External Vendors

Geographical Scope

Provide onsite support to Dadra, other site whenever

needed.

Financial Accountability (cost/revenue with exclusive authority)

Based on Approved Budgets for the sites – Both Opex & Capex

Job Requirements

Educational Qualification

BE/B. Tech, MCA, BCA, MSc IT, BSc. IT, Graduation +

PGDCA.

Specific Certification

NA

Experience

9 years + in IT activities preferably in Pharma

Manufacturing.

Skill (Functional & Behavioural): QI support, CSV Support, IT regulatory requirements, Validation & Qualification activities as per standards, backup related activities.