Job Description

Job Title:

ITQC

Job Grade:

Executive



Department:

IT

Sub-function:

ITQC



Manager\xe2\x80\x99s Job Title:

Location IT

Skip Level Manager\xe2\x80\x99s Title:

Sr. Manager



No. of Direct Reports (if any)

Location IT/Cluster lead

Location:

Jammu




Job Summary




Area Of Responsibility



To maintain software related data of laboratory instrument / Equipment as an Application Administration. To perform activities like creation / modification / Disable /Re-activate of user Account (s) And Assigning Privileges. To maintain the user Account Request / Record of User(s) To perform the Activities like Project creation, Archival and Backup & Restoration of data as an application administration To perform the Activities of Laboratory instrument software\xe2\x80\x99s like Archival / Backup, Restoration To perform the periodic activities like User access review, Roles & Privileges review, Validation review of Laboratories GxP applications To perform the IT administration activities for Analytical balances and pH meters used in the quality Control Laboratory To prepare and review of validation deliverables during the validation of GxP applications To prepare, review and execution of qualification test cases. To coordinate and verify that the all validation activities and documents comply with applicable regulations and internal procedures at all locations To follow and comply time line adherence with the new IT project Plan and csv compliance. To monitor and maintain record of site IT compliance status. Computer system validation and QC Application support to other SUN PHARMA location. Facilitate internal and regulatory agency audits, ensuring that findings from site QC audits are understood, assessed and addressed site wise in a comprehensive manner



Work Conditions:

Required minimum 3-4 years\xe2\x80\x99 experience in Pharma company.



Physical Requirements:

Candidate should be knowledge in QC instruments and software like Empower, labsolutions labex. Responsible to support site applications other than QC, whenever required



Travel Estimate

N/A



Education and Job Qualification



Graduation / BCA, BSC IT,



Experience




Specific Certification

N/A



Skills

Knowledge of GXP systems computer applications validation in pharma company.






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).