Should be proficient for working with analytical software like Empower etc
Should have worked in GxP compliant environment with respect to administration of analytical software, various mfg. applications and managing IT, OT Infrastructure Services
Should be having the knowledge of 21 CFR part 11 and Annex 11 with respect to data management and storage.
Description of Job:
To administer analytical software like Empower & other instrument software and support day to day requirement for the same.
Management of users in analytical software and Mfg. systems in terms of creation, modification or removal of the same as per defined procedure.
Configure the access privileges in instrument / analytical software to functional users as per defined procedures.
Troubleshooting of day to day issues in analytical software and provide the operation support for all the plant IT and OT applications
Hands-on experience for working with various IT infrastructure technologies like Windows Server OS, Desktop OS, LAN etc.
Experience in writing, reviewing and executing Validation Documentation in GXP environment for various IT and OT related processes
Should aware about computer System Validation Life Cycle (GAMP 5), GxP, GAMP and CFR's.
Knowledge on SOPs, work instructions, and regulatory requirements to the validation of computerized systems
To ensure all computerised systems used to support GMP manufacture, are appropriately validated and controlled
Support during any FDA and other regulatory audits from IT and OT documentation and other IT Infrastructure prospective
Should have good manufacturing process knowledge in Pharmaceutical industry.
Expected Qualification:
BE Computer / IT / MCA (preferable) or Graduate with similar experience
Expected Work Experience:
At least 5-6 years of working experience in GxP area.
Should have good manufacturing process knowledge in Pharmaceutical industry
