Sterility Assurance Manager
Thermo Fisher Scientific
17 gg fa

Job Description

The candidate will ensure that the aseptic production processes are robust and that the highest level of sterility is assured, in full compliance to Company’s standards, SOP, cGMP and requirements.

S / he will join a fast-growing and dynamic function that operates in an international environment, supporting pharmaceutical industries across the world, and will report directly into site Quality Director, gaining an exposure to corporate levels, clients and regulatory agencies.

The candidate will leverage his / her strong technical background, as well as the abilty to succesfully partner with the production function at all levels, to maintain a world-

class standard of sterilty assurance.

Essential Functions

  • Proactively work with other functions so that processes and equipment are constantly improved and that site Sterility Assurance level is enhanced
  • Analyze process critical phases and equipment status so that the corrective and preventive actions are properly identified and optimal maintenance planning is in place.
  • Collaborate with other functions in managing events, deviation and issues that have an impact on sterility.
  • Evaluate changes that could potentially have an impact on sterility.
  • Support validation team in defining the validation approach on new equipment, processes or new production areas
  • Ensure surveillance of maintenance activities in Sterile departments, supporting technical and production functions so that the risk of external contamination is minimized.
  • Ensure that environmental monitoring trends are correctly analyzed
  • Train as required on sterility matters according to the Training Master Plan
  • Skills

  • At least 10 year of experience with sterile drug manufacturing
  • Knowledge of the pharmaceutical Industry and GMP, aseptic techniques and processes (lyo and liquid injectable drugs)
  • Strong microbiology background
  • Analytical skills, proactive, result-oriented, excellent relationships skills at all levels;
  • Fluent English (speaking, reading, writing)
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