Title:  Senior Executive

1 | P a g e Job Description Position for Sr. Executive – Information Technology The Job holder will be responsible to Lead the Quality Informatics Team and maintain software related data of Laboratory Instrument / Equipment’s as an Application Administrator and perform the activities of Laboratory instruments and also for Manufacturing System software’s like Archival / backup, restoration, validation & qualification etc.. Lead team as LIT. Areas Of Responsibility  Manage and perform Quality Management System like Change Control/Deviation etc.  To maintain software related data of Laboratory Instrument / Equipment’s as an Application & System. Administrator.  To perform activities like creation / modification /Disable / Re-activation of User Account(s) and assigning of privileges for both windows & application.  To prepare, review configuration specification documents.  To prepare and review standard operating procedures associated with the planning, development and operation of IT related systems.  To maintain User Account Request / record of user(s) for both windows & application.  To perform the activities of Server software like: Project creation, template migrations, Archival / backup of soft data, Restore projects.  To perform the activities of standalone Laboratory instruments software’s like Archival / backup, restoration etc.  To prepare periodic review scheduler and execute periodic review of each instrument accordingly.  To control and maintain the Password of Analytical Balances, pH meter and Stability chambers (HMI) used in the Quality Control Laboratory.  To prepare validation / Review documents such user as requirement specifications, validation plans, test plans, summary test result and final validation reports.  IT activity related to IQ/OQ/PQ and configuration policies for standalone Laboratory instrument software.  To coordinate and verify that all validation activities and documents comply with applicable regulations and internal procedures at all locations.  To follow and comply timeline adherence with the new IT project plan and CSV compliance.  To monitor and maintain record of Quality Control IT compliance status.  To support site IT for regulatory compliance.  Support for handling deviation and CAPA effectiveness related to QC driving them down.  Accountable for designing/implementing and ensuring compliance to all quality related, Policies, Standards and IT systems at QC of the site.  Facilitate internal and regulatory agency audits, ensuring that findings from site QC audits are understood, assessed and addressed site wise in a comprehensive manner. Travel Estimate Based on the need job holder can travel to other sites. 2 | P a g e Job Description Job Scope Internal Interactions (within the organization) QI and CSV Teams, Business Users, Corporate IT & Plant Management Teams External Interactions (outside the organization) Business Users, External Vendors Geographical Scope Provide onsite support to Dadra, other site whenever needed. Financial Accountability (cost/revenue with exclusive authority) Based on Approved Budgets for the sites – Both Opex & Capex Job Requirements Educational Qualification BE/B. Tech, MCA, BCA, MSc IT, BSc. IT, Graduation + PGDCA. Specific Certification NA Skills QI support, CSV Support, IT regulatory requirements, Validation & Qualification activities as per standards, backup related activities. Experience 9 years + in IT activities preferably in Pharma Manufacturing. Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).