Senior Executive -IT Quality Compliance

Job Title:

IT Quality Compliance

Job Grade:

G12A/ G11B

Function

Global Information Technology

Location:

Toansa

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.”

Responsibilities :

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

·       To maintain Software related data & & Software inventory of Laboratory Instrument / Equipment’s as an Application Administrator in Site QC Lab, GP&T Lab and Pilot Plant Lab.

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

·       To maintain User Account Request / record of user(s).

·       To perform the activities of Empower software like: Project creation, template migrations, Archival / backup of soft data, Restore projects, Channel unlocking etc.

·       To perform the activities of 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 Instruments (Analytical Balances, pH meter and Halogen Moisture analyzer) used in the Quality Control Laboratory, GP&T Lab and Manufacturing areas. 
• To prepare validation documents such as requirement specifications, configuration specification, validation plans, test plans, summary test result and final validation reports.
• IT activity related to IQ/OQ/PQ and configuration policies for 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 CSQMS procedure compliance.
• To monitor and maintain record of site IT compliance status.
• Responsible to support site IT team for preparation of validation documents & Quality Management System (QMS) documents (Deviation, Incidents, CAPA etc.).
• To support site IT for regulatory compliance.
• Support for handling deviation related to QC 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.

·       Responsible for Central administrator for QC Laboratory applications hosting at other sites i.e. Chennai, Guwahati, Dewas API & DF, Jammu, Bangalore, GOA, Baddi etc. 

·       Responsible to support site applications other than QC, whenever required.

·       Computer System Validation and QC Application support as Technical Owner/ Application Administrator to Sun Pharma locations

Travel Estimate

Need Based

Job Scope

Internal Interactions (within the organization)

QC Lab, Microbiology Lab, GP&T, Stability Labs, Ware house, IPQA Labs, Pilot Plant Lab

External Interactions (outside the organization)

Other Sites of Sun Pharmaceutical Industries Ltd

Job Requirements

Educational Qualification

BE/B.Tech, MCA, BCA, MSc.-IT, BSc.-IT,

Experience

7+ Years

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!