Systems Operations Specialist

2 days ago

Hyderabad, Telangana, India beBeeManufacturing Full time ₹ 10,50,000 - ₹ 1,41,99,000
Expert in Manufacturing Systems

This role involves providing technical expertise to support all electronic batch record (eBR) related issues. The Expert will collaborate closely with various teams, including Quality and Automation.

  • Define User requirement specifications based on customer input
  • Design and create electronic batch files while adhering to quality, cost, and deadline requirements
  • Develop Master Batch Records, Bill of Materials, and Recipes within production IT systems
  • Participate in qualification and risk assessment processes
  • Propose and validate technology solutions from IT and Automation teams in collaboration with the Quality team
  • Deploy Manufacturing Execution Systems across manufacturing units, perform performance qualification and validation batches, and commission new lines in conjunction with manufacturing units
  • Update manufacturing documentation following electronic batch file implementation
  • Provide training for MES users in partnership with the training team
  • Ensure timely processing and follow-up of deviations and Change Control in compliance with deadlines and applicable regulations
  • Conduct real-time shop floor troubleshooting with immediate corrective actions
  • Transfer information to production teams regarding technical, quality, or HSE impacts
  • Responsible for transferring MES/MIS technical knowledge to the shop floor
  • Prepare audits and inspections for related topics
  • Collaborate with process experts concerning MES/MIS-related deviations and continuous process improvement
  • Participate in change management in close collaboration with change champions and P&O partners
  • Apply local rules, procedures, and policies

Essential Requirements:

  • Minimum 5 years experience in GMP manufacturing process support role
  • Proven experience in MES expert role
  • University degree in Science is required (Pharmacy, Chemical Engineering, Pharmaceutical Technology, or equivalent)

Competencies:

  • Good scientific and technical understanding of automation
  • Deep process understanding
  • Quality and compliance skills
  • Team player with strong team spirit
  • Change management, adaptability, and ability to work under pressure
  • Mastering of automation and computer skills
  • Good understanding of regulatory requirements across multiple health authorities
  • Mastering of manufacturing execution systems (MES, SAP, or other as applicable)
  • Good office software applications

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