Quality Assurance Manager

vor 4 Wochen

Bern, Schweiz agap2 - HIQ Consulting Vollzeit

agap2 is a European engineering and operational consulting group founded in 2005 and specialized in the industry. We work in the Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology sectors.

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.

Tasks
  • 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.
Requirements
  • University degree with a first experience in Pharma Industry (GMP)
  • Proven Experience in management of deviations, Redaction CAPAs, Change controls and risk analysis
  • English and German spoken and written
  • Analytical thinking and problem-solving skills.
  • Communication skills and good negotiation skills.
  • Excellent interpersonal and team collaboration skills.
Benefits

Working with agap2 means...

  • Joining a group with strong development potential that aims to improve your employability on challenging and varied projects
  • Joining a structure that has been established in Switzerland for a long time with a client portfolio that includes the leaders in the sector
  • Having a sustainable job with stability and access to a real collaboration
  • Benefit from training with accredited and certified centers
  • Having a local management to support you in the achievement of your missions and in the development of your career
  • Being part of a dynamic, committed team with real human values that we live by every day

Only applications from Swiss and EU citizens will be considered (UK excluded).

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