Job Description

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):
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!
Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of the incumbent(s).

Skills Required