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)
