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Quality Control Microbiology Coordinator

Zakłady Farmaceutyczne Polpharma S.A.

Starogard Gdański, pomorskie

Zakłady Farmaceutyczne Polpharma S.A.

RESPONSIBILITIES:

  • Establishing and operation of Quality Control Microbiology laboratory
  • Introduction and upkeep of GMP system in the laboratory
  • Managing and coordination of the activities of reporting team
  • Performing all duties according to current applicable GMP rules and other pharmaceutical regulations
  • Preparation and review of microbial method validation, qualification of equipment and microbial method transfer
  • Preparation and review of protocols, reports, procedures and all required documents
  • Sampling and testing of: clean utilities, raw materials, product - IPC, final product
  • Preparation of reagents and reagent management
  • Participation in internal and external audits

 

REQUIREMENTS:

  • Higher education in microbiology, biology, biotechnology, chemistry, pharmacy or related disciplines
  • Minimum 5 years of work experience at similar position
  • Theoretical and practical knowledge of methods transfer, environmental, water and compressed gases monitoring, microbial identification, endotoxin testing, microbial testing of raw materials, IPC and final product, QC of microbial media
  • Advanced knowledge of the GLP and GDP regulations
  • Experience in participation in internal and external audits
  • Proficiency in English, both written and spoken
  • MS Office knowledge
  • Ability of independent problem solving, analytic thinking, good organizational skills and leadership skills
  • Ability to prioritize and meet demanding deadlines and timescales in a fast moving environment

 

WE OFFER:

  • Contributing to the success of modern, rapidly growing pharmaceutical company
  • Motivating salary appropriate for competence and performance
  • Opportunity for professional development
  • Comprehensive benefits package

 

Zakłady Farmaceutyczne Polpharma S.A.
Zakłady Farmaceutyczne Polpharma S.A.

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