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IT Operation and compliance

4.00 to 5.00 Years   Bangalore   06 Feb, 2020
Sygene
Job LocationBangalore
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaIT Operations / EDP / MIS
EmploymentTypeFull-time

Job Description

Qualification : M.Sc./B.E. with minimum 4-5 years of working experience with Pharmaceutical / Life science client.Total Experience: 5-6 YearsTechnical Skills

  • Hands on experience on QC instruments application backup like KF-Auto Titrator spectrophotometer, LC/MS, HPLCs, GCs, NMR,FT-IR, Ph-Meter.
  • Hands on experience on production related equipment s formulation i.e (Tab compression, tab coating, encapsulation) and API i.e. (reactors, Blenders, dryers)
  • Hands on experience on production related automation product/ (PLCs, SCADA, DCS).
  • Hands on experience on back up of informatics application like Chromeleon, Empower LIMS.
  • Hands on experience on Lab Computing support covering lab instrument back up.
  • Candidate should be well versed with backup and restore procedure keeping regulatory compliance audits.
  • Should have strong understanding for 21CFR part 11 specially data integrity and compliance.
Roles and Responsibilities:
  • Identify: Identify the data from QC and production related instrument/equipment which requires back up as part of compliance.
  • Configuration/Monitoring: Ensure the data backup up configuration and daily monitoring with the help technical team. Identify RPO/RTO
  • Restoration: Instrument/equipment data restoration/verification along with users in compliance to regulatory and GMP expectation.
  • Audits: Demonstrate the data backup process in various regulatory and client audits.
  • Work with Various teams to cater instrument/application data backup needs.
  • Liaison with vendors for the technical issues/ escalations.
  • Perform the changes as required in the environment, in line with the change management policies.
  • Analyze and plan for the desired storage space requirement for Syngene, ensure the optimum storage is available.
  • Establish best practices for data backup to ensure compliance towards BCP/DR.
Experience:
  • Solid technical background combined with customer service experience
  • Industry experience 4-5 years must.
Other Skills
  • Ability to work within an interdisciplinary research team.
  • Good written and communication skills.
,

Keyskills :
data integritycustomer service regulatory compliancechange management working experiencedata backup interdisciplinary research

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