Title:  Executive/Sr.Executive Quality Informatics-IT

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!