Executive IT -Quality Informatics

• 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.

1. 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.

2. 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.

3. 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.

1. 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.

2. 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

Do you have experience in Systems & applications support?, 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!