Lausanne

QA Pharmaceutical Specialist

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Information
  • Location: Lausanne
  • Position: QA Pharmaceutical Specialist
  • Sector: Life Sciences
  • Type of contract: Permanent contract
  • Starting date: ASAP

As a consultant, you will have to support our clients in the realization of their projects on site by bringing your expertise and your skills. You are agile and eager to adapt to different work environments that will fuel your curiosity of seeing what’s behind closed doors of the biggest projects of our client’s portfolio. You are a permanent and valuable part of our teams, being supported by your designated technical business manager and a secure, stable work environment for you.

Your main missions are:

  • Ensure that products, systems and equipment are in sustainable compliance with GMP and regulatory requirements.
  • Ensure efficient and effective quality assurance activities at the required GMP level.
  • Responsible for all documentation associated with the area of quality, pharmaceutical standards and norms.
  • Review and approve SOPs and other quality related documents.
  • Review and approve raw materials.
  • Review and evaluate global change controls.
  • Review and approve event and deviation reports. Evaluate event and deviation reports to determine if they need to be forwarded to the Quality Development Manager.
  • Ensure appropriate and effective CAPAs are defined with appropriate timelines and ensure timely implementation.
  • Ensure appropriate coverage of CAPAs with effectiveness checks, monitor their execution and evaluate results.
  • Review and approve certifications for health authorities.
  • Support the compilation of PQRs.
  • Improve understanding of GMPs through team training
  • Support the inspection team during the preparation, execution and follow-up of inspections and audits.

 

This job is made for you if.

  • You hold a Msc or Phd with a first experience in Pharma Industry (GMP).
  • You have a proven Experience in Management of deviations, Redaction CAPAs, Change controls and risk analysis.
  • You are fluent in French and English.
  • You have an analytical thinking and problem-solving skills.
  • You have communication skills and good negotiation skills.
  • You have an excellent interpersonal and team collaboration skills.

Working with us means.

  • Being an expert in a fast-paced and diverse environment.
  • Joining an organically fast-growing company.
  • Working in an agile company with startup feeling.
  • Joining a team guided by shared values, respect, trust and fun.
  • Meeting wonderful people and their network.
  • Facing technical challenges in changing industries.
  • Chance to speed up and improve your career.
  • Having choice of projects, follow ups and trainings.
  • Being valued and not just one of many.

 

For agap2, all talents count. If you have a disability, do not hesitate to ask questions and to apply.