Work as Instrument Data Manager at Syngene International
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