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Quality Control Qualification and Validation Specialist.

Job Details

zusammenfassung.

  • Branche
    Life sciences
  • Kontakt
    Nicolae-Ionut Baias
  • Referenznummer
    18274

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Job Details

For our client, an international company in Bern  we are looking for 
Quality Control Qualification and Validation Specialist
 

  • Start date: 01.02.2023
  • End:  31.12.2023
  • Extension: possible
  • Workplace: Bern
  • Workload: 100%



Tasks and Responsibilities

  1. Coordination of equipment/system qualification and validation activities within the QC department (e.g. clarification with vendors and the QC testing labs, writing technical documents) including collaboration with interdepartmental stakeholders Define the validation strategy
  2. Perform and/or support the writing of specification documents (URS)
  3. Review test protocols, plans and reports
  4. Support test execution
  5. Decommissioning qualified/validated equipment and systems through Change Control procedures
  6. Supporting the timely and effective completion of investigations, change controls and CAPA’s

Must have:
  • Degree in a LifeSciences/ Biotechnology, Chemistry discipline or comparable work experience
  • Experience working with QC equipment
  • Several years of experience in qualification of laboratory and analytical equipment in Pharma
  • Good understanding of analytical technologies,
  • Strong analytical thinking and problem-solving ability
  • Excellent communication and teamwork skills
  • Ability to simultaneously support multiple projects, duties and assignments and prioritize accordingly
  • Excellent writing skills for scientifically sound technical documents, instructions, protocols and reports.
  • Good verbal and written skills in English, German is a plus

 

    For our client, an international company in Bern  we are looking for 
    Quality Control Qualification and Validation Specialist
     

    • Start date: 01.02.2023
    • End:  31.12.2023
    • Extension: possible
    • Workplace: Bern
    • Workload: 100%



    Tasks and Responsibilities

    1. Coordination of equipment/system qualification and validation activities within the QC department (e.g. clarification with vendors and the QC testing labs, writing technical documents) including collaboration with interdepartmental stakeholders Define the validation strategy
    2. Perform and/or support the writing of specification documents (URS)
    3. Review test protocols, plans and reports
    4. Support test execution
    5. Decommissioning qualified/validated equipment and systems through Change Control procedures
    6. Supporting the timely and effective completion of investigations, change controls and CAPA’s

    Must have:
    • Degree in a LifeSciences/ Biotechnology, Chemistry discipline or comparable work experience
    • Experience working with QC equipment
    • Several years of experience in qualification of laboratory and analytical equipment in Pharma
    • Good understanding of analytical technologies,
    • Strong analytical thinking and problem-solving ability
    • Excellent communication and teamwork skills
    • Ability to simultaneously support multiple projects, duties and assignments and prioritize accordingly
    • Excellent writing skills for scientifically sound technical documents, instructions, protocols and reports.
    • Good verbal and written skills in English, German is a plus

     

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      Nicolae-Ionut Baias

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