Syngene International is one of India’s premier contract research and manufacturing organizations in providing customized service. Our services encompasses all across discovery chain: early stage discovery, process development, cGMP manufacturing and formulation development both in the small molecule and novel biologics area. Based in Bangalore, Karnataka, the Company is situated in a 90 acre Special Economic Zone with over 100000 sq. mt of built up facilities. The state-of-the-art research facilities have been qualified by various pharmaceutical majors & regulatory agencies and has received various certifications including ISO 9001: 2008, ISO 14001:2004, OHSAS 18001:2007, GLP and AAALAC.
Post : Instrument Data Manager
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.
• M.Sc./B.E. with minimum 4-5 years of working experience with Pharmaceutical / Life science client.
• Solid technical background combined with customer service experience
• Industry experience 4-5 years must.
• 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.
Qualification : M.Sc./B.E
Location : Bangalore
Experience : 4-5 Years
Industry Type : Pharma
End Date : 10th November, 2018
See All Other Jobs in our Database