Managing in global environment

Managing in global environment

Subject: Managing in global environment

At UC, it is a priority that students are provided with strong educational programs and courses that allow them to be servant-leaders in their disciplines and communities, linking research with practice and knowledge with ethical decision-making. This assignment is a written assignment where students will demonstrate how this course research has connected and put into practice within their own career.

Assignment:
Provide a reflection of at least 500 words (or 2 pages double spaced) of how the knowledge, skills, or theories of this course have been applied, or could be applied, in a practical manner to your current work environment. If you are not currently working, share times when you have or could observe these theories and knowledge could be applied to an employment opportunity in your field of study.

Requirements:

  • Provide a 500 word (or 2      pages double spaced) minimum reflection.
  • Use of proper APA      formatting and citations. If supporting evidence from outside resources      is used those must be properly cited.
  • Share a personal      connection that identifies specific knowledge and theories from this      course.
  • Demonstrate a connection      to your current work environment. If you are not employed, demonstrate a      connection to your desired work environment.
  • You should NOT, provide an      overview of the assignments assigned in the course. The assignment      asks that you reflect how the knowledge and skills obtained through      meeting course objectives were applied or could be applied in the      workplace.

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My profession is validation Engineer ( in a pharma company I validate equipment)

below are my job roles. I am sending my job roles at a high level.

Need this assignment in 4 hours.

 

Job Responsibilities

· Generates, executes and reviews protocols and SOPs for Autoclave, Clean Steam Generators, Purified water systems, RABS, AHU’S, HVAC system, compressed air (process air), ISO rooms (ISO 9,8,7), Reach-In Coolers, Walk-In coolers, Walk-In Freezers, Parts washer.

· Developed/executed qualification protocols URS, DQ, Commissioning/IQ/OQ/PQ and SOP’S.

· Ensure that all the documentation is compliance with FDA and CGMP regulations and provides technical support to the validation group as needed

· Complete and execute validation protocols and reports, Risk and Impact assessment as well as Validation strategy, in a timely and compliant manner to meet project objectives

· Performed risk assessments and setting up risk priorities for manufacturing equipment.

· Developed sampling strategies and effective techniques to collect samples to improve existing protocol and collected the sampling locations for swabbing from protocols.

· Trained and worked on aseptic sampling, aseptic clean hold time studies, Bioburden sample collection, TOC and Endotoxin sample collection, Rinse and negative control sample collection and SWAB sampling.