Job Description:

• Ensure cGMP, Positive Documentation Practices (GDP), Data Integrity, and Data Security Policies are followed.

• Oversee and validate various software in quality control and assurance functions, such as HPLC, IR, UV, and Stability Control systems.

• Manage user accounts, roles, and access rights for quality systems and instruments.

• Backup/archive QC data and ensure its secure storage and restoration.

• Perform administrative tasks for software and hardware systems used in QA/QC departments.

• Coordinate remediation of IT controls in manufacturing systems, focusing on deletion restrictions, user access management, and data backup.

• Conduct cross-functional activities with other departments to ensure alignment with quality standards.

• Train quality control staff on IT system usage and data security practices.

• Monitor and review QMS activities to identify areas for process improvement.

• Lead audits to ensure compliance with regulatory requirements in IT and QMS domains.

• Stay updated with evolving regulatory guidelines in the pharmaceutical sector.

📌 Pharma IT (Amreli)
🏢 Pramukh Staffing
📍 Amreli