Lead Instrument Data Manager

  • Company:
    Syngene International Ltd
  • Location:
  • Salary:
    negotiable / month
  • Job type:
    Full-Time
  • Posted:
    1 week ago
  • Category:
    Healthcare | Biotechnology/Pharmaceutical/Medicine

Skill: production equipment , scada , capacity planning , dcs , plcs , technical skills; Exp: 9-10 years; Career Opportunities Lead Instrument Data Manager (3480) Req Id 3480 – Posted 08/13/2018 – India Technical Skills Candidate should be well versed with informatics/instrument application used in the pharmaceutical domain. (CDS, ELN, LIMS, KF-Auto Titrator spectrophotometer, LC/MS, HPLCs, GCs, NMR, FT-IR, Ph-Meter etc.) Candidate should have expertise in managing the data backup and restore process in life science domain in adherence to data security, data traceability and data integrity. Candidate should have expertise in meeting the computing needs of production equipment like (PLCs, SCADA, DCS). Hands on experience on back up of informatics application like Chromeleon, Empower LIMS. Candidate should be well versed with backup and restore procedure keeping regulatory compliance. Should have strong understanding for 21CFR part 11 specially data integrity and compliance. Knowledge of ITIL or equivalent process. Roles and Responsibilities Supervisory responsibility of overseeing Storage and Backup team. Supervise Technical staff, manage assignments, complete work performance reviews, and determine training requirements. Manage Storage & Backup administration, capacity planning, tuning, and architecture design for all systems under support Ensures Instrument/equipment data restoration/verification along with users in compliance to regulatory and GMP expectation Ensure the defined RPO and RTO are met as per the defined procedure and guidelines. Manage all infrastructure planning, management and support activities for areas of responsibility under Storage & Backup Platform. Demonstrate the data backup process in various regulatory and client audits. Work with Various teams to cater instrument/application data backup needs. Ensure vendor management for maintaining the SLAs. 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 Life Science Industry experience 4-5 years must Other Skills Ability to work within an interdisciplinary research team. Good written and communication skills. Location Bangalore Qualification M.Sc./B.E. with minimum 4-5 years of working experience with Pharmaceutical / Life science client. Total Experience 9-10 Years

Production/Manufacturing/Maintenance

Degree: ME/ M.Tech./ MS (Engg/ Sciences)

Experience: 9-10

Function: Production / Maintenance / Service Engg. / Manufacturing / Packaging