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LOLonza

Senior GMP Validation Scientist – Validation Strategy & Documentation Physico-Chemical Quality Control(m/w/x)

Basel
Full-timeOn-siteSenior

Evaluating and transcribing new analytical test methods, supporting laboratory setup. Expert experience with laboratory specific software like CDS Empower required. Independent validation strategy and documentation.

Requirements

  • BSc/MSc in analytical chemistry, biochemistry, or related field
  • Extensive working experience in research/technical role in pharmaceutical or chemical industry
  • Proven track record in applying analytical methods in QC or GMP regulated laboratory
  • Advanced scientific knowledge of physico-chemical analytical methods
  • Expert experience with laboratory specific software (e.g. CDS Empower)
  • Advanced knowledge in reporting, interpretation, and documentation of scientific results
  • Good communication and interpersonal skills
  • Ability to work independently and in a team
  • Good knowledge of written and spoken English

Tasks

  • Evaluate new analytical test methods during pre-validation activities
  • Transcribe test methods according to Lonza requirements
  • Support laboratory setup by ordering necessary materials
  • Conclude validation, transfer, or verification independently
  • Plan and document protocols and reports
  • Communicate efficiently to align with internal and external stakeholders
  • Manage stakeholder relationships and communicate validation risks
  • Ensure compliance and maintain up-to-date training status
  • Assist in investigations and propose mitigation measures
  • Initiate and participate in improvement initiatives

Work Experience

  • approx. 4 - 6 years

Education

  • Vocational certificationOR
  • Bachelor's degreeOR
  • Master's degree

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • CDS Empower

Benefits

Career Advancement

  • Agile career

Informal Culture

  • Dynamic work culture
  • Inclusive workplace

Purpose-Driven Work

  • Ethical workplace

Bonuses & Incentives

  • Compensation programs for high performance
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