1 Pharmacy manager job in the Canton of Jura

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Commissioning, Qualification and Validation Consultant H/F

Southern Switzerland
12.05. | Position with re­spon­si­bil­i­ties | 100%

Commissioning, Qualification and Validation Consultant H/F

Job Description


Key role:


As a consultant, you will support our client to all their industrial project in validation process. As Qualification & Validation Engineer, your role will be to ensure that the process of qualification is done with the right level of quality and follow regulation, such as GMP, client’s expectation.


 


Key responsibilities:


  • Coordinate activities with the supplier, manage aspects of the logistic process,

  • Create a detailed schedule of qualification activities in collaboration with project manager,

  • Commissioning and qualification of equipment (FAT / SAT),

  • Participate in the writing process of draft risk analyses and criticality analyses,

  • Implement the qualification master plan and deploy the strategy to the system concerned,

  • Carry out qualification activities (IQ; OQ; PQ), and collate all documentation,

  • Read and validate all project deliverables, and ensure consistency and quality through all documentation,

  • Suggest optimizations based on best practice approach and experience with procedures.

Profile


  • Advanced technical degree (Master in Quality, in Pharmacist, Industrial Pharmacist...) in Bio- pharma or related fields;

  • Experience of min. 10 years in the Biopharmaceutical / Life science industry in GMP environments in Quality Management according to FDA, Eudralex vol.4, ICH Q8/Q9/Q10, cGMPs;

  • Excellent knowledge of English. German will be considered a strong asset.

  • Well organized and independent in daily task with a good team spirit

  • Ability to cope in very fast-moving environment

  • Be proactive, and suggest improvement with impact and effect

  • Effective communicator with the ability to relate easily with people

  • Solid interpersonal and influencing skills, at ease with all levels of hierarchical positions.