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Executive/Sr.Executive Quality Informatics-IT
Title: Executive/Sr.Executive Quality Informatics-IT
Date: Apr 15, 2026
Location: Baska 2 Plant
Company: Sun Pharma Medicare Ltd
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):
Strong 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).
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