Microbiology and Sterilization Specialist – Praca na etat, Poznań Sady

Miejsce pracy: Wielkopolskie / Poznań, Wysogotowo– gmina Tarnowo Podgórne

LiNA Medical Polska Sp. z o.o. – producent urządzeń medycznych w obszarze ginekologii małoinwazyjnej poszukuje pracownika na stanowisko: Microbiology and Sterilization Specialist

Status Oferty Pracy: Nieaktualna
Dział: QA
Rodzaj pracy: Pełen etat

List of responsibility:

  • Overall responsibility for microbiology analysis of products, raw materials, clean room environment and personnel
  • Being up to date with regulatory requirements and standards within area of responsibility
  • Participation and performing clean room qualification according to related standards (e.g. ISO 13485, ISO 14644, EN 17141)
  • Supervision of maintaining of cleanroom class requirements and associated controlled environment
  • Supervision of clean room physical parameters, cleanliness of clean room equipment and clothing
  • Perform analysis of environment and personnel contamination
  • Participation in risk assessment process
  • Review of microbiology/particles data from external origin
  • Participation and coordination of ETO Sterilization external process
  • Being in contact with sterilization service provider
  • Review and approval process for validation of sterilization (protocols and reports) – ISO 11135, ISO 11137
  • Creation and update of the quality documentation according to the quality standards implemented within the company
  • Follow the OOS procedure/NC procedure
  • Training of employees from all microbiological / sterilization / Clean room related issues

Qualifications and competences:

  • Fast learning and open minded
  • Excellent communication skills
  • Efficient, accurate, work according to plan
  • Flexible and pro-active
  • Positive & problem solving attitude
  • Relevant education and/or experience
  • Work experience within Medical Devices or Pharmaceutical industry is an advantage
  • Experience in laboratory is an advantage
  • Familiar with ETO sterilization method
  • Familiar with ISO 13485, ISO11135, ISO11137, ISO14644)
  • Experience in microbiological area
  • Fluent English – verbal and written
  • IT on a user level
  • Driving license cat.B
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