Executive IT -Quality Informatics

Job Description:

Responsibilities

• 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.

Qualifiication & Experience

• Bachelor’s degree in Computer Science, Information Technology, Engineering, Pharmacy, or Science
• Specific Certification
• Experience
• 3-5 years of relevant experience in:
• IT support for pharmaceutical or regulated environments
• Computerized System Validation (CSV)
• Laboratory systems and instrument software