Job Summary/ 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."
Computer System Qualification & Validation (CSV)
Ensure
hardware qualification
of computerized systems is completed as per approved protocols.
Prepare, review, and execute
qualification and validation documents
for computerized systems and laboratory instruments.
Perform and review
software validation
for new instruments in line with
21 CFR Part 11 requirements
.
Implement system and software validation for newly installed instruments/software.
2. Regulatory Compliance – 21 CFR Part 11
Maintain and secure
21 CFR Part 11 compliance
of laboratory instruments and equipment.
Ensure compliance related to
ERES, audit trails, software categorization, user and role management
, and data security.
Act as
administrative rights holder
for instrument and equipment software installed at SPML Baska.
3. System Administration & IT Support
Preparation, review, and approval of
System Administrator procedures
for QC instrument software.
Perform IT‐related activities as defined in instrument/equipment SOPs.
Execute
DTC‐related activities
for the IT department.
Monitor EDMS form due dates and system documentation lifecycle.
4. SOPs, Documentation & QMS
Review, prepare, and maintain SOPs related to:
Backup of electronic data
System control policies
IT infrastructure and system security




Preparation, review, and approval of
IT‐related protocols, policies, and documentation
.
Preparation, review, and approval of
QMS documents
as per internal procedures.
Maintenance of
Computerized System (CS) Software Inventory
.
5. User Management & Governance
Approval of
user management requests
, role assignments, access control forms, and infrastructure‐related documents.
Ensure periodic review of user access and system roles to maintain compliance and data integrity.
6. Periodic & Compliance Activities
Perform all
periodic activities
as defined in SOPs.
Support internal and external audits related to computerized systems and data integrity.
Job Scope
Internal Interactions (within the organization)
Quality Control (QC) Department
Quality Assurance (QA)
IT Department
Validation & Compliance Team
Engineering & Instrumentation Team
Regulatory Affairs (as required)
Documentation / QMS Team
Internal Audit Team
Department Heads and System Owners
External Interactions (outside the organization)
Instrument and software vendors
Service engineers and AMC providers
Geographical Scope
Primary responsibility:
SPIL – Baska, Gujarat
Financial Accountability (cost/revenue with exclusive authority)
NA
Job Requirements
Educational Qualification
Bachelor's degree in
Computer Science, Information Technology, Engineering, Pharmacy, or Science
Specific Certification
NA
Experience
3-5 years
of relevant experience in:




IT support for pharmaceutical or regulated environments
Computerized System Validation (CSV)
Laboratory systems and instrument software
Hands‐on experience with:
Backup, restoration, and archival systems
Software validation and qualification activities
Regulatory audits (USFDA, MHRA, WHO, etc.)
Experience working in
QC laboratories
or GMP‐regulated manufacturing facilities preferred
Skill (Functional & Behavioural):
Robust knowledge of
21 CFR Part 11
,
Data Integrity
,
ERES
, and
Audit Trails
Expertise in
Computer System Validation (CSV)
and software qualification lifecycle
Experience in
system administration
for laboratory instruments and software
Good understanding of
EDMS, QMS
, and documentation control
Backup management, disaster recovery, and restoration validation
SOP writing, review, and compliance management
Ability to manage user access control and role‐based security
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).

📌 Executive/Sr.Executive Quality Informatics-It (India)
🏢 Sun Pharmaceutical Industries
📍 India