Deviation Specialist

vor 2 Wochen

Lausanne Metropolitan Area, Schweiz GXP CONSULTING Switzerland Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

Did you ever want to work for a company placing human at the heart of its DNA? Are you ready to make a difference? Do you feel excited about the opportunity to collaborate and share your expertise with our industry leaders? YES? so do WE

GXP CONSULTING
Switzerland is a Swiss company with a passionate team of Life Sciences professionals. Since 2014 we deliver outstanding industry's expertise and support to our clients in the complete range of product life cycle.

As a
Deviation Lead
, you will be responsible for managing deviations within the
MSAT
scope. You will play a key role in deviation investigations, implementation of corrective and preventive actions (CAPA), and driving continuous quality improvements.

Main Responsibilities

  • Deviation Management
    :
  • Own, record, author, and investigate deviations.
  • Liaise with
    Subject Matter Experts (SMEs)
    and key stakeholders to identify root causes and assess the potential impact of deviations.
  • Apply structured investigational tools (e.g., Fault Tree Analysis, Fishbone Diagram, Event & Causal Factors Chart, Defense Analysis) to determine root causes and contributing factors.
  • Define, implement, and monitor appropriate
    CAPA
    and related effectiveness checks.
  • Ensure compliance with
    cGMP
    requirements and drive quality records to timely and successful closure.
  • Training Management:
  • Encode and track departmental trainings in the electronic learning system.
  • Ensure proper documentation and compliance in training records.
  • Continuous Improvement & Quality:
  • Actively contribute to improvement initiatives (CCP, CAPA, etc.).
  • Support the business through change management and process optimization activities.

Candidate Profile

  • University degree in a scientific or technical field (pharma, engineering, biotechnology, or equivalent).
  • Previous experience managing deviations in a pharmaceutical or biotech environment.
  • Experience in a
    production environment USP / DSP
    is a strong asset.
  • Strong knowledge of
    cGMP
    and quality investigation tools.
  • Ability to work cross-functionally with Engineering & Maintenance, Quality, Production, and other departments.
  • Excellent communication skills, analytical mindset, and attention to detail.

About us:

  • Human-sized company with great colleagues from a large diversity of cultural and professional backgrounds
  • We do care about our people, communicate openly and value feedback
  • Work as a team where every member is valued and appreciated
  • Opportunity to contribute to ambitious projects within an international and multicultural environment that fosters innovation, collaboration, and professional growth.
  • Continuous learning and development opportunities via internal or external training and workshops
  • Competitive salary package in line with industry practice together with exceptional employment benefits

At GXP Consulting Switzerland everyone contributes to our joint success and grows individually

If you also share the same passion and values, we will be glad to hear from you

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