QA Microbiology Expert (m/w/d).

Job ID: 11141

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Discipline
Quality/Production
Type of employment
Project Consulting
Company
Entourage is a management and personnel consultancy focusing on pharmaceuticals, medical technology and health care. The company, which is based in Munich and Basel, recruits experts for the leading life science companies in the DACH region by placing permanent scientific employees and consultants. With Project Consultants, Entourage implements projects for its clients via highly qualified temporary employment agencies and work contracts. With the Entourage Task Force (ETF), Entourage bundles selected interim managers and management consultants into a top-class consulting unit that implements pharmaceutical and medical technology solution scenarios in consulting projects on an interdisciplinary basis.
Responsibilities
  • Monitoring, control and evaluation of all microbiology topics
  • Quality Assurance View for the Manufacture and / or Release of Drugs, Active Ingredients and raw materials
  • Supervision and cooperation with the requirements for hygiene at the site
  • Supervision, control and implementation of the general requirements and as well as the internal Quality Manual (QM Modules, SOP) on all topics related to microbiology
  • QA Oversight for Microbiological Topics:
    • Supervision of microbiological monitoring of the environment (air, surfaces and gases) and cleaning agents and disinfection, in good time and in accordance with c-GMP, Quality Manual and SOPs.
  • Decision on 'critical' and 'non-critical' Microbio deviations and complaints and approval of the respective Microbio risk assessments with Microbio theme.
  • Collaborate with process units, QA, QC or other teams to streamline processes and products produced, and ensure compliance with regulatory requirements.
  • Support for qualification/validation of production areas and equipment; Elaboration / cooperation of / in qualification / validation documents (protocol and report), including trouble shoot, if there are deviations from microbiology or hygiene.
  • Support in preparation for government inspections, customer audits, internal audits and microbiology expert participation.
  • Carrying out self-inspections and supervision activities concerning general hygiene standards at the site
  • Monitor site hygiene standards and oversee related CAPAs, actions or trainings are needed

Requirements
  • Education:
    Microbiology, Pharmacy or biotechnology or significant work experience in the microbiology area
  • Minimum 3 years of experience in the QA Microbiology area for a pharmaceutical or similar industry
  • Fluency in German and English
  • Result oriented, experienced on team work and collaborations across departments and sites
Region
Süd