Senior Executive IT-Quality Informatics

Job Title:

Senior Executive IT- Quality Informatics

Job Grade (refer to JE)

G12A/G11B

Function:

Information Technology

Sub-function:

Quality Informatics

Location:

Dadra

Areas Of Responsibility

At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine?

As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”

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.

Responsibilities:

• 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 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 Laboratory 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.
• 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

3-9 year

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

Your Success Matters to Us

At Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!