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Senior Operations Manager

2 mesi fa


Monza, Lombardia, Italia Thermo Fisher Scientific A tempo pieno
Job Summary

We are seeking a highly skilled and experienced Senior Operations Manager to lead our PDS Master Batch Record team at Thermo Fisher Scientific. As a key member of our dynamic organization, you will be responsible for overseeing daily operations, fostering a positive work environment, and ensuring team members are motivated and equipped to achieve their goals.

Key Responsibilities
  • Team Management: Manage a team of 3 employees, including recruitment, training, performance management, and career development.
  • Foster a Culture of Collaboration: Encourage a culture of collaboration, accountability, and continuous improvement.
  • Performance Monitoring: Monitor team performance against key performance indicators (KPIs) and targets.
  • Identify Areas for Improvement: Identify areas for improvement and implement strategies to optimize team productivity and efficiency.
  • Communication: Facilitate open and effective communication within the team and with other departments.
  • Ensure Compliance: Ensure that Master Batch Records are issued in order to ensure cGMP compliance with EMA and US FDA requirements.
  • Personnel Training: Provide personnel training, checking of correct applications of GMP and operating procedures.
  • Project Implementation: Full cooperation in the different phases of the projects implementation and validation.
  • Change Control: Ensure that CAPAs and action from Change Control are implemented in the MBRs.
  • Client Communication: Involvement in the technical meeting with the clients for the introduction of the new process/products in our PDS sterile departments and for the revision of MBR instructions directly with client through call or dedicated meeting.
  • Internal Audits: Active participation in internal audits, client audit/Regulatory inspections.
  • Client Requests: Management of the client's requests about production processes.
  • Collaboration: Collaboration with the whole QO, Process Scientist, MSAT, Equipment Validation, Supply chain, Production Dept.
Requirements
  • Education: Degree in Chemistry, Chemical, Pharmaceutical Technology or Industrial Engineering or equivalent.
  • Experience: GMP, Pharma background, manufacturing of sterile products knowledge is preferred.
  • Skills: Strong communication, interpersonal, and problem-solving skills.
  • Ability: Ability to work effectively in a fast-paced and dynamic environment.
  • Language: Good knowledge of the English language (both written and spoken).