Microbiological Supervisor for New Products
Δ/Δ
Αθήνα, GR
πριν από 6 μέρες
source : Kariera.gr

Περιγραφή Θέσης

Microbiological Supervisor for New Products

The candidate will work in a Greek pharmaceutical company (located in the North-Western region of Athens) with more than 40 years of experience.

The company manufactures both sterile and non-sterile products and is focused on exports worldwide.

The candidate will supervise the Microbiological team which is responsible for the transfer and validation of all microbiological methods for new products.

Responsibilities :

  • Method development, validation and transfer of the microbiological analyses of sterile, non-sterile products and raw materials, including but not limited to :
  • Bioburden testing
  • Sterility Testing
  • Bacterial Endotoxin testing
  • Filter Validation
  • Bioassay
  • Conducts the Gap Analysis of the products dossiers
  • Responsible for the timely execution of Microbiological Technology Transfer activities in compliance with cGMP legal and regulatory requirements and with company’s Quality Manual and Policies
  • Ensures development and optimization of analytical methods for cleaning validation
  • Authoring and / or reviewing the Microbiological Method Validation / Verification / Transfer Protocols and reports
  • Ensures that the newly developed analytical methods are robust and effective in the commercial laboratory environment
  • Responsible for the daily program of the Microbiological team
  • Evaluates and implements new technologies required to maintain state-of-the-art analytical methods for development and market products
  • Prepares and participates in inspections and audits
  • Responsible for the team budget preparation and ensures that the approved budget is met
  • Communication with the customers regarding the implementation and progress of the projects.
  • Qualifications :

  • Professional experience of at least 3 years in a pharmaceutical company in an QC or R&D Microbiological laboratory
  • Bachelor’s degree in Biology
  • MSc in Microbiology will be desirable
  • Fluency in English both written and oral
  • Excellent computer literacy (Microsoft Office)
  • The Company offers a challenging European environment with constant upgrade and competitive salary depending on candidate’s qualifications.

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