Manager, IT (Gxp)

Manager, IT (Gxp)

02 Nov 2021
New Jersey, Baskingridge, 07924 Baskingridge USA

Manager, IT (Gxp)



JOB DESCRIPTION

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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