02 Nov
Manager, IT (Gxp)
Vacancy expired!
- 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.
- 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.
- BE Computer / IT / MCA (preferable) or Graduate with similar experience
- At least 5-6 years of working experience in GxP area.
- Should have good manufacturing process knowledge in Pharmaceutical industry
Vacancy expired!