Job Title: Executive - IT
Purpose of Job
To manage IT operations, ensuring compliance with industry regulations such as GxP, 21 CFR Part 11 and QMS.
Skill Required
1) GxP (Good Automated Manufacturing Practice), 21 CFR Part 11 compliance (FDA regulations for electronic records), GAMP 5 (Good Automated Manufacturing Practice guidelines)
2) LIMS (Laboratory Information Management Systems), QMS (Quality Management Systems), MES (Manufacturing Execution Systems), Endpoint protection and secure access control, Backup and disaster recovery systems
Roles and Responsibilites
1) Manage day-to-day IT operations, including infrastructure, networks, hardware, and software.
2) Ensure all IT systems meet pharmaceutical regulatory compliance standards (e.g., GxP, FDA, EMA).
3) Support for the implementation and maintenance of enterprise systems such as ERP, LIMS, QMS, and MES.
4) Collaborate with Softfloor user, manufacturing, QA/QC, and regulatory teams to align IT solutions with business needs.
5) Manage vendors, contracts, and service-level agreements (SLAs).
6) Develop and implement IT policies, procedures, and best practices.
7) Ensure cybersecurity and data protection measures are in place and up to date.
8) Plan for disaster recovery and business continuity.
9) Monitor emerging technology trends relevant to the pharmaceutical industry.
Qualification Required
Bachelor's degree in Computer Science, Information Technology, or related field (Master’s preferred).
08-10 years of IT experience, with at least 3 years in a team lead role.
Prior experience in a pharmaceutical, biotech, or regulated industry is highly desirable.
Strong knowledge of pharmaceutical regulatory requirements (e.g., GAMP 5, 21 CFR Part 11, GxP).
Relevant skills / Industry experience
Relevant professional / Educational background
Any other requirements (If any)
Compensation / Reward
SEZ, Ahmedabad, GJ, IN, 382213