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RYVU THERAPEUTICS

Quality Specialist (GCP)

RYVU THERAPEUTICSO firmie

RYVU THERAPEUTICS

Michała Bobrzyńskiego 14

Kraków

Quality Specialist (GCP)
Location: Kraków

Key responsibilities are:

  • Developing and implementing Quality Management System (QMS) to ensure compliance with regulatory authority guidelines as well as company SOPs
  • Maintains elements of QA systems, including the creation/revision of appropriate SOPs, Deviations, CAPAs, Audits/metrics and development of quality control plans
  • Supports clinical operations in ensuring that clinical studies maintained in compliance with study protocols, GCP as well as any applicable regulatory requirements
  • Developing, reviewing, approving, implementing of SOPs related to GCP
  • Conducts internal SOPs training for employees
  • Schedules and maintain internal and external audit plans
  • Conducts routine internal audits
  • Provides contribution where required to review key documents such as study protocols, informed consents, investigator brochures, clinical study reports etc
  • Supports continues improvement of QMS
  • Facilitation activities in regulatory inspections
  • Provides GCP guidance and interpretation of GCP regulations as required

Your background should include:

  • MSc degree with 3 - 5 years of related experience in biotech/pharmaceutical industry in regulated environment
  • Advanced understanding of quality management system based on GCP/GLP/GMP regulations
  • Experience in GCP environment is desired
  • Experience in audits and inspections of regulatory authorities is welcome
  • Advanced knowledge of FDA, EU regulations as well as ICH guidelines applicable to study conduct
  • Proficiency in MS suit

What we offer:

  • Competitive base salary and bonus opportunities 
  • Private medical care 
  • Life insuarance
  • Training programs: internal scientific, lectures, expert and peer coaching
  • Language lessons in English or Polish
  • Conference attendance sponsorship
  • MultiSport Card
  • Volleyball and Football teams 
  • On-site gym
  • Lunch benefits and fruits in the office
If you are interested please apply by clicking below button.
 
 

We kindly ask you to add the following clause to your application: „I hereby express my consent to the processing of my personal data by Ryvu Therapeutics SA for the purpose of existing recruitment process”. If you want us to keep the submitted documents also for the purposes of future recruitment processes, we kindly ask you to add the following clause to your application: „I hereby express my consent to the processing of my personal data by Ryvu Therapeutics SA for the purpose of future recruitment processes for a period of 3 years from the date of submission of this document, in order to analyze them in terms of the recruitment processes carried out in the Ryvu Therapeutics SA”

Quality Specialist (GCP)

Key responsibilities are:

  • Developing and implementing Quality Management System (QMS) to ensure compliance with regulatory authority guidelines as well as company SOPs
  • Maintains elements of QA systems, including the creation/revision of appropriate SOPs, Deviations, CAPAs, Audits/metrics and development of quality control plans
  • Supports clinical operations in ensuring that clinical studies maintained in compliance with study protocols, GCP as well as any applicable regulatory requirements
  • Developing, reviewing, approving, implementing of SOPs related to GCP
  • Conducts internal SOPs training for employees
  • Schedules and maintain internal and external audit plans
  • Conducts routine internal audits
  • Provides contribution where required to review key documents such as study protocols, informed consents, investigator brochures, clinical study reports etc
  • Supports continues improvement of QMS
  • Facilitation activities in regulatory inspections
  • Provides GCP guidance and interpretation of GCP regulations as required

Your background should include:

  • MSc degree with 3 - 5 years of related experience in biotech/pharmaceutical industry in regulated environment
  • Advanced understanding of quality management system based on GCP/GLP/GMP regulations
  • Experience in GCP environment is desired
  • Experience in audits and inspections of regulatory authorities is welcome
  • Advanced knowledge of FDA, EU regulations as well as ICH guidelines applicable to study conduct
  • Proficiency in MS suit

What we offer:

  • Competitive base salary and bonus opportunities 
  • Private medical care 
  • Life insuarance
  • Training programs: internal scientific, lectures, expert and peer coaching
  • Language lessons in English or Polish
  • Conference attendance sponsorship
  • MultiSport Card
  • Volleyball and Football teams 
  • On-site gym
  • Lunch benefits and fruits in the office
If you are interested please apply by clicking below button.
 
 

We kindly ask you to add the following clause to your application: „I hereby express my consent to the processing of my personal data by Ryvu Therapeutics SA for the purpose of existing recruitment process”. If you want us to keep the submitted documents also for the purposes of future recruitment processes, we kindly ask you to add the following clause to your application: „I hereby express my consent to the processing of my personal data by Ryvu Therapeutics SA for the purpose of future recruitment processes for a period of 3 years from the date of submission of this document, in order to analyze them in terms of the recruitment processes carried out in the Ryvu Therapeutics SA”

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