02 Nov
Manager, IT (Gxp)
New Jersey, Baskingridge , 07924 Baskingridge USA


Preferred Work Experience:
  • 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

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