Global Process and Technology Audit Manager

2 months ago

bangalore, India CliniSys Full time

Essential Functions

  • Develop and implement process improvement initiatives
  • Analyze current processes and identify areas for improvement
  • Design and implement new processes to increase efficiency and productivity
  • Manage process documentation and ensure compliance with company standards
  • Collaborate with cross-functional teams to implement process changes
  • Train employees on new processes and procedures
  • Monitor and measure process performance and report on progress
  • Responsible for taking action based on audits and CAPA findings
  • Identify and mitigate process risks and issues
  • Lead process improvement projects from start to finish
  • Partner with Quality and Regulatory to ensure processes meet regulatory needs
  • All other duties and responsibilities as assigned

Skills needed to be successful

  • Proven work experience as a Process Manager or similar role
  • Excellent understanding of process improvement methodologies
  • Strong analytical and problem-solving skills
  • Ability to lead and manage cross-functional global teams
  • Excellent communication and interpersonal skills
  • Ability to work under pressure and meet deadlines
  • Excellent computer skills, including proficiency in Microsoft Office and process mapping software
  • Solid understanding of Agile software development methodologies

  • Certification in process improvement methodologies such as Lean Six Sigma is a plus
  • Previous experience in project management is a plus

Required Experience & Education

  • Bachelor's degree in Business Administration, Engineering, or a related field. Master's degree in Business Administration or a related field is preferred.
  • This is a senior position that requires a minimum of 5 years of experience in process management or related field.
  • Previous experience with requirements and certifications required for FDA or any other governing bodies for e.g. ISO 13485 .
  • Experience in a scientific testing or healthcare field is a plus.

Supervisory Responsibilities

  • None

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