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)
