Qualification Expert

Vor 6 Tagen

Basel, Basel-Stadt, Schweiz D-ploy Vollzeit
About the Role

We are seeking a highly skilled and experienced Qualification Expert to join our team at D-ploy. As a key member of our IT and Engineering Solutions team, you will be responsible for delivering innovative and superior services and solutions to our industry-leading clients.

Key Responsibilities
  • Prepare and execute computer-based system qualification deliverables, including project plans, HLRA, URS, QPlan, IQ, OQ, PQ, ERES assessment and Verification, Q-Report, risk assessment, decommissioning test plan, and SOP, in a pharmaceutical environment.
  • Review qualification deliverables generated by project team members and provide feedback for improvement.
  • Migrate computer-based lab equipment systems, including Operating System and Data.
  • Provide technical support to onsite lab IT supporters in troubleshooting and system configuration specific topics.
  • Assist the Service Coordinator and Service Delivery Manager in delivering and project managing processes to complete projects within timeline and budget.
  • Act as Subject Matter Expert for qualification purposes and Point Of Contact for regulatory inspections and audits.
  • Support and deputize colleagues onsite.
Requirements
  • Big pharma experience, document creation experience, GxP, and IO OQ PQ basic experience.
  • Working knowledge of qualification processes and Computer System Validation concepts.
  • Good understanding of and motivation for working in regulated environments, including GxP methodologies, 21 CFR Part 11 compliance, ALCOA+ principles, and latest industry expectations for Data Integrity.
  • Lab environment, ITIL, and IT knowledge is an advantage.
  • Excellent communication skills with clients, 3rd party, project managers, and team members.
  • Proven ability to prioritize and manage multiple demands, projects, and cross-functional teams.
  • Experienced in technical communication, including technical writing, instructional design, technical editing, copy editing, or proofreading, and quality assurance.
  • Good at gathering feedback and implementing improvements.
  • Self-responsible, self-organized, and flexible person.
  • Multi-tasking and handling changes in requirements or schedule.
  • Willingness to work at different customer locations.
  • Fluent in English (spoken & written), German is an advantage.
  • Candidates must provide a Criminal record extract not older than three months.
What We Offer
  • Broad range of activities, tasks, and projects.
  • Lunch Checks or Reka Money (Lunch Checks can be used in 7000+ restaurants, Reka Money can be used for Transport & Accommodation, Sport & Wellbeing, Leisure & Culture, Holidays & Travel).
  • Enjoy free refreshments in our D-ploy offices.
  • Insurance Benefits.
  • Fishing for Friends program – our referral program.
  • Further development and professional advancement.
  • Friendly and international working environment.
  • Competitive salary and various benefits.

If you believe you are a good match for this role, we are keen to speak with you. You can apply through our website or by reaching out directly to our recruitment team.

  • Qualification Expert

    Vor 6 Tagen

    Basel, Basel-Stadt, Schweiz D-ploy Vollzeit

    About D-ployD-ploy is a leading IT and Engineering Solutions company with a strong presence in the EMEA region and the USA. We pride ourselves on delivering innovative and superior services and solutions to industry-leading clients.Job SummaryWe are seeking a highly skilled and experienced Qualification Expert to join our team. As a Qualification Expert, you...

  • Qualification Expert

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz D-ploy Vollzeit

    About D-ployD-ploy is a leading provider of IT and Engineering Solutions, serving clients across the EMEA region and the USA. Our company prides itself on delivering innovative and superior services and solutions to numerous industry-leading clients.We build relationships and trusted partnerships within the IT community, optimizing our customers' IT...

  • Qualification Expert

    Vor 6 Tagen

    Basel, Basel-Stadt, Schweiz D-ploy Vollzeit

    About the RoleD-ploy is a leading IT and Engineering Solutions company with a strong presence in the EMEA region and the USA. We pride ourselves on delivering innovative and superior services and solutions to industry-leading clients.We are seeking a highly skilled and experienced Qualification Expert to join our team. As a key member of our team, you will...

  • Qualification Expert

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz D-ploy Vollzeit

    About D-ployD-ploy is a leading provider of IT and Engineering Solutions, with a strong presence in the EMEA region and the USA. We pride ourselves on delivering innovative and superior services and solutions to numerous industry-leading clients.We are a dynamic and international organization, committed to creating value where IT counts. Our team is focused...

  • Expert People Care Specialist

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Lonza AG Vollzeit

    About the RoleAs an Expert People Care Specialist at Lonza AG, you will play a vital role in supporting the well-being and resilience of our employees. This is a unique opportunity to make a meaningful difference in the lives of our people and contribute to the success of our organization.Key ResponsibilitiesEmployee Support and Guidance: Provide expert...

  • CSV Engineer

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz agap2 - HIQ Consulting Vollzeit

    About agap2 - HIQ ConsultingWe are a European engineering and operational consulting group founded in 2005, specializing in various industries, including Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology.As a trusted partner, we support our clients in achieving their project goals by...

  • Expert People Care Specialist

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Lonza AG Vollzeit

    About the RoleAs an Expert People Care Specialist at Lonza AG, you will play a vital role in supporting the well-being and resilience of our employees. This is a unique opportunity to make a meaningful difference in the lives of our people and contribute to the success of our organization.Key ResponsibilitiesEmployee Support and Case Management: Provide...

  • Supply Chain Planning Expert

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Infosys Technologies Vollzeit

    About the RoleWe are seeking a highly skilled Supply Chain Planning Expert to join our team at Infosys Technologies. As a Kinaxis Rapid Response Specialist, you will be responsible for providing clients with deep expertise in the Supply & Inventory Planning domains of Kinaxis Rapid Response.Key ResponsibilitiesProvide clients with deep expertise in the...

  • Supply Chain Planning Expert

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Infosys Technologies Vollzeit

    About the RoleWe are seeking a highly skilled Supply Chain Planning Expert to join our team at Infosys Technologies. As a Kinaxis Rapid Response Specialist, you will be responsible for providing clients with deep expertise in Supply & Inventory Planning domains.Key ResponsibilitiesDesign and implement Supply Networks & Resources in KinaxisGuide the...

  • CSV Engineer

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz agap2 - HIQ Consulting Vollzeit

    About agap2 - HIQ ConsultingWe are a European engineering and operational consulting group founded in 2005, specializing in various industries, including Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology.As a trusted partner, we support our clients in achieving their project goals by...

  • Biomarker Experimental Medicine Lead

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Roche Vollzeit

    About the RoleWe are seeking a highly experienced Biomarker Experimental Medicine Lead to join our Translational Medicine Group in the Ophthalmology department. As a key member of our team, you will be responsible for developing and implementing forward and reverse translational biomarker strategies during pre-clinical and clinical phases of individual drug...

  • SAP Inhouse Consultant

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz BROMsolutions AG Basel Vollzeit

    {"Your Challenge": "As a SAP Inhouse Consultant - Customer Experience Expert at BROMsolutions AG Basel, you will be part of the global SAP CX CoE Team, driving all CX projects and operational activities.Key responsibilities include:Implementing new solutions in our key marketsDeveloping, implementing, and maintaining solutions within SAP Commerce...

  • Pharmaceutical Quality Control Expert

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    About the RoleWe are seeking a highly skilled Quality Assurance Manager to join our team at Gi Group SA. As a key member of our Quality Operations Unit, you will be responsible for ensuring the quality and compliance of our Investigational Medicinal Products (IMPs) manufactured and packed for clinical studies in Switzerland.Key ResponsibilitiesImplementation...

  • Quality Assurance Specialist

    Vor 4 Tagen

    Basel, Basel-Stadt, Schweiz Gi Group SA Vollzeit

    Job DescriptionWe are seeking a highly experienced Qualification Expert to join our team at Gi Group SA. As a key member of our quality assurance team, you will be responsible for planning and conducting qualification and validation activities, creating and reviewing qualification and validation documents, and ensuring compliance with internal and external...

  • Regulatory Compliance Professional

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz D-ploy Vollzeit

    About D-ployD-ploy is a leading provider of IT and Engineering Solutions, serving clients across the EMEA region and the USA. Our company prides itself on delivering innovative and superior services and solutions to numerous industry-leading clients.We build trusted partnerships within the IT community, optimizing our customers' IT productivity and...

  • Computer System Validation Specialist

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz D-ploy Vollzeit

    About D-ployD-ploy is a leading IT and Engineering Solutions company with a strong presence in the EMEA region and the USA. We pride ourselves on delivering innovative and superior services and solutions to numerous industry-leading clients.We are a dynamic and international organization that values relationships and trusted partnerships within the IT...

  • Process Automation Expert

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz emerson Vollzeit

    Job SummaryWe are seeking a highly skilled and experienced Senior Control Systems Engineer to join our team at Emerson. As a key member of our applications engineering field, you will be responsible for designing and implementing project-specific Process Control System solutions that meet the requirements of both our end-users and our business.As a part of...

  • CSV Engineer

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz agap2 - HIQ Consulting Vollzeit

    About agap2 - HIQ ConsultingWe are a European engineering and operational consulting group founded in 2005, specializing in the industry. Our expertise spans across various sectors, including Pharma, Biotechnology, Medical Devices, Energy, Infrastructure, Transportation, Chemicals, and Information Technology.Job DescriptionWe are seeking a skilled CSV...

  • Procurement Manager

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz BakerHicks Vollzeit

    About the RoleWe are seeking a highly skilled Procurement Manager to join our team at BakerHicks. As a key member of our procurement team, you will be responsible for managing the procurement process from pre-qualification to contract commitment.Key ResponsibilitiesDevelop and implement procurement strategies to ensure compliance with company policies and...

  • Food Category Manager

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Viking Vollzeit

    About the RoleViking is seeking a highly skilled Food Category Manager to join our Purchasing and Procurement department. As a key member of the team, you will assist the Senior Purchasing Manager in sourcing all food items for our fleet, ensuring that all products needed for onboard hotel operations are delivered on time and at the lowest total cost of...