Sterility Assurance Manager

2 weeks ago

Singapore Thermo Fisher Scientific Full time
Scope of role/responsibility

  • Guarantee that the production process of the injectable sterile pharmaceuticals are designed and driven In order to ensure the appropriate sterility assurance level (SAL) in conformity procedure and the cGMP normative
  • Support the site concerning the organization of training on Sterility Assurance matters
  • Guarantee assistance during the regulatory inspections regarding sterility assurance
  • Be a SME in the Global Sterility Assurance Group, representing the site and acting as a SPOC to demonstrate global experience
  • Provide guidance and direction in the implementation of the site contamination control strategy (CCS)

Specific responsibilities/main activities:

Sterility Assurance

  • Create the CCS for the site in compliance to Regulations, demonstrating standard methodologies and continuous evolution in the requirements from Regulators and Clients
  • Coordinate the site Media Fill program to assure a critical approach to introduction of new products, areas, equipment, changes, and proper planning of MF activities
  • Provide guidance on the design of and provide oversight to the effectiveness of the EM system, identify any weaknesses, and initiate any required improvement
  • Support the surveillance of the maintenance activities to be carried out within the sterile department, in respect to the current procedures, giving the necessary directions so that such interventions are performed to reduce the environmental contamination and the product risk to a minimum
  • Collaborate within the investigation team for the management of the quality events with an impact on sterility, supporting the evaluations on deviations and complaints with microbiology impact
  • Review & approve any Major/Critical deviation and any corrective and preventive actions with Sterile Assurance impact
  • Actively participate in the identification, development and/or review and revision of SOPs that have impact on the sterility assurance as well as evaluation of changes.
  • Participate to the review of data from EM, aimed at identifying any trend and establishing proper counter measures
  • Research, in collaboration with other company teams and functions, an improvement of the processes and systems to increase the SAL
  • Report regularly the status of and promote Sterility Assurance within the site Senior Leadership Team
  • Responsible for the Aseptic training programs at site. Carry out the training for the topics of competence, when found necessary or when requested (Training Master Plan)
  • Review the surveillance plan of the aseptic technique activities, the identification, and implement the eventual corrective actions in order to fill the gap identified (overlooking and Fit & Finish)
  • Support the Validation team in the qualification and validation approach definition of new instruments\\processes (HVAC, sterilization\\depyrogenation, classification rooms, media fill). in terms of sterility assurance
  • Support the Engineering in the definition of the projects of new utilities, new production areas or installations of new equipment, in terms of sterility assurance especially in the design phase
  • Support the auditing activities at other sterile sites and suppliers providing microbiological service or sterile materials (as required)

Requirements:

Education:

  • Degree / Master Degree in a Scientific Area (Pharma or Biotech Field, Microbiology Field can be preferred)

Technical skills:

  • Basic and Specialist Analytical techniques
  • Background on sterility assurance, on process and cleaning validation concepts and CCS relations
  • Statistical knowledge
  • Knowledge of computer systems and data management tools, and LIMS systems

Professional background:

  • 10+yrs of experience in Quality department of manufacturing sites with sterile production
  • Within the testing laboratory or microbiological quality control laboratory within chemical pharmaceutical international companies (preferably FDA Approved)
At Thermo Fisher Scientific, each one of our 100,000 outstanding minds have a unique story to tell. Join us and contribute to our unusual mission—enabling our customers.

  • Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status._

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