Senior Quality Representative (w/m)


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As team member of Global Quality Control technical support - technical oversight you would be responsible for:

  • Support and lead oversight of analytical method lifecycle during clinical and commercial stages from initial delivery through routine use, replacement and obsolescence
  • Design method validation strategy together with method experts
  • Review and approve method validation protocols
  • Support and oversee method transfer strategy and comparability testing
  • Approve method transfer plans and protocols
  • ensure analytical method validations are compliant to applicable internal and external guidelines and procedures
  • Review and approve investigations of method related laboratory exceptions. Define appropriate corrective actions together with investigation team.
  • act as SME and technical advisor in the field of method validation and calibration of reference standards
  • Act as a link between Global QC departments (method introduction, analytical lifecycle management)
  • Oversee centralized ownership of analytical methods through centralized control and distribution of harmonized procedures
  • Serve as technical SME for responsible programs during agency inspections

Qualifications

  • Leadership capabilities
  • Several years of relevant industry experience
  • Works autonomously
  • Requires knowledge and proficiency in the design, execution, and validation of analytical techniques used in the laboratory such as HPLC, SDS-PAGE, Capillary Electrophoresis, Potency and Bioassays
  • Ability to troubleshoot method performance and propose corrections is essential
  • Background in analytics or natural sciences (university degree or similar)
  • Quality Control and method validation experience
  • Fluent in English and German
  • Excellent communication skills in a cross-cultural and cross-department environment
  • Excellent communication, interpersonal and organizational skills
  • Ability to work well both independently and in a team environment.
  • Ability to prioritize work and multitask
  • Project management experience would be a plus
  • Self-driven, highly motivated, cooperative and proactive
  • Organizational and problem solving skills
  • six sigma experience would be a plus
  • Project management experience would be a plus
  • Knowledge concerning cGMP (mainly QC related)
  • Willing to travel

Company Insights https://youtu.be/ly_8oO-iJeU
Your application should include motivation letter and CV. Remuneration corresponds to the respective classification according to the collective agreement. The minimum salary for this position is €   3,065.25 gross per month (full-time). Increased payment is possible. In addition we offer many social benefits (e.g. canteen, wellness-center, company kindergarten) to mention just a few of them.
We offer outstanding opportunities to committed and talented people. Sex, age, color of skin, origin, ethnicity, sexual orientation as well as a physical handicap do not matter to us. On the contrary: We promote diversity in every field.

Austria

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