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BakerHicks

Designs and delivers engineering projects

Qualification Lead

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours
Full-timeBasel, SwitzerlandNo salary listed

About the Job

Requirements

  • You have a completed degree in engineering, natural sciences, or an equivalent qualification.
  • You have several years of experience in qualification or validation in a GMP-regulated environment, ideally in the pharmaceutical industry.
  • You have sound knowledge of GxP, quality systems, and regulatory requirements such as EU GMP and the US FDA.
  • You have leadership experience in projects or interdisciplinary teams.
  • You have very good spoken and written German and English.

Responsibilities

  • You lead qualification activities in technical projects and are responsible for quality, schedule, and budget within your area.
  • You create, review, and approve qualification-related GMP documents such as URS, QP, DQ, IQ, OQ, and change requests.
  • You ensure GMP-compliant implementation of all qualification processes within the project team and at external partners.
  • You provide subject-matter leadership and efficiently coordinate cross-functional project teams.
  • You work closely with QA, engineering, operations, suppliers, and project management to ensure smooth workflows.
  • You monitor the progress of qualification activities and provide regular status reports.
  • You are responsible for the final handover of all qualification documentation to the life-cycle qualification team.
  • Depending on the project and project phase, you work primarily at the customer's project site; some work from home may be possible by agreement.
  • You may work on projects in different customer environments and locations.

Desired Qualifications

  • Experience in the pharmaceutical industry is ideal.

About the Company

BakerHicks

Designs and delivers engineering projects

BakerHicks provides design, engineering and project delivery services for buildings, industrial facilities and infrastructure across the United Kingdom and Europe. Its multidisciplinary teams combine architecture, civil and structural engineering, building services and process expertise for clients in regulated and technically complex settings. Work spans aviation, rail, power, nuclear, life sciences, manufacturing and public facilities, with services adapted to each project and sector. The company supports projects from planning and design through construction, commissioning, handover and operational management. Founded in 1957, it is headquartered in Warwick, Warwickshire.

Company size
1,001-5,000
Company stage
Not listed
Total funding
Not listed
Headquarters
Warwick, United Kingdom
Founded
1957

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