Are you looking for your next project in the pharmaceutical industry? Read on!
About the Client
Our client is an international leader in biotech and pharmaceutical production, with a strong footprint in Switzerland. Their facility in the Valais region operates at the forefront of bioprocessing innovation, combining technical excellence with an inspiring alpine setting. The site offers professionals a unique chance to develop their careers within a progressive and collaborative atmosphere.
Job Description
In this position, you will lead the creation and oversight of validation activities to support consistent and compliant biopharmaceutical manufacturing. You'll play a vital role in process documentation, regulatory interaction, and interdepartmental collaboration. From design through continued verification, your work ensures robust quality standards. The role provides valuable exposure to both technical and strategic quality operations.
Responsibilities
- Design comprehensive process validation plans that meet industry regulations.
- Draft, review, and finalize validation protocols, reports, and assessments.
- Contribute to process characterization in partnership with R&D.
- Evaluate and authorize changes, deviations, and non-conformance events.
- Lead the development and maintenance of the continued process verification strategy.
- Provide input into Product Quality Reviews for life-cycle monitoring.
- Liaise with internal stakeholders to align validation and quality efforts.
- Engage with regulatory authorities when necessary.
Requirements
- Master's degree in Chemistry, Biology, Biotechnology, Chemical Engineering, or related field.
- Proven background in project management within a GMP setting.
- Prior involvement in MSAT, Quality Assurance, or Operations.
- Exposure to biologics, particularly mammalian systems, is beneficial.
- Strong organizational skills with an ability to manage multiple priorities.
- Fluent in English; German language knowledge is a plus.
Benefits
- Contract for 7 months with Oxford Global Resources.
- Work at a pharmaceutical leader in a state of the art facility.
- Commuting allowance.
