Qualification Expert

vor 1 Woche

Basel, Basel-Stadt, Schweiz D-ploy Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

D-ploy is an IT and Engineering Solutions company with operations throughout the EMEA region including Switzerland, Germany, Czech Republic, Austria, UK, as well as the USA.

We pride ourselves on delivering innovative and superior services and solutions to numerous industry-leading clients. By building relationships and trusted partnerships within the IT community, we optimize our customer's IT productivity and contribute to the organization's success and value.

We are interested in talking to engaging, flexible, and solution-oriented individuals who are looking to become a part of a dynamically growing and international organization. We are focused on creating value where IT counts, join us

Tasks and Responsibilities
  • Preparation and execution of computer-based system qualification deliverables (project plan, HLRA, URS, QPlan, IQ, OQ, PQ, ERES assessment and Verification, Q-Report, risk assessment, decommissioning test plan, SOP) in a pharmaceutical environment (laboratory, production)
  • Review of qualification deliverables generated by project team members
  • Migration of computer-based lab equipment systems (Operating System, Data etc.)
  • Provide help to onsite lab IT supporter in troubleshooting or system configuration specific topics
  • Assist the Service Coordinator and Service Delivery Manager in the delivery and project management processes required to complete projects within timeline and budget
  • 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 (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 client, 3rd party, project manager and team members
  • Proven ability to prioritize and manage multiple demands, projects and cross-functional teams
  • Experienced in technical communication, which includes but is not limited to 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 and German (spoken & written)
  • Candidates must provide Criminal record extract not older than three months
Benefits
  • 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

Is IT in your DNA?

If you believe you are a good match for this role, or any other opportunities for which D-ploy is currently staffing, then we are very keen to speak with you. You can apply though a variety of channels, including our website www.d- or by reaching out directly to our recruitment team -

  • Business Expert

    Vor 7 Tagen

    Basel, Basel-Stadt, Schweiz Apple Vollzeit CHF 60'000 - CHF 120'000 pro Jahr

    Apple Retail is where the best of Apple comes together. We bring our expertise to help people do what they love, delivering an only-at-Apple experience. We believe inclusion is a shared responsibility and we work together to foster a culture where everyone belongs and is inspired to do their best work. As a Business Expert, you're part of a team that's...

  • Senior Expert

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Novartis AG Vollzeit CHF 65'060 - CHF 86'000 pro Jahr

    Senior Expert - Medical Device Analytical Representative (f/m/d) Job ID REQ Nov 19, Schweiz Summary #LI-Hybrid Internal job title: Senior Expert - Science & Technology Location: Basel, Switzerland or Schaftenau, Austria With the increasing diversity of Novartis' portfolio, the need for drug-device combination product analytical data packages is also...

  • Medical Expert

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz BioVersys AG Vollzeit CHF 120'000 - CHF 180'000 pro Jahr

    Bioversys AG is an innovative biotech company in clinical-stage development in Basel. To grow the team, we are seeking a Medical Monitor to support global late-stage clinical trials in infectious diseases and antimicrobial resistance. The position reports to the Medical Director and plays a central role in overseeing complex, multi-regional studies —...

  • Structure Elucidation Expert with Focus on Mass Spectrometry

    vor 1 Tag

    Basel, Basel-Stadt, Schweiz Roche Vollzeit CHF 80'000 - CHF 1'100'000 pro Jahr

    At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure...

  • Senior QA Compliance Expert

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Arcondis Group Vollzeit CHF 100'000 - CHF 120'000 pro Jahr

    Job OverviewFor our Swiss and EU based pharmaceutical clients we are seeking an experienced Senior QA Compliance Specialist fulfilling also the requirements to act as "Fachtechnisch verantwortliche Person (FvP)" according to Swiss Arzneimittel-Bewilligungsverordnung (AMBV), as well as "verantwortliche Person Betäubungsmittel) according to Swiss...

  • QA Engineer

    Vor 3 Tagen

    Basel, Basel-Stadt, Schweiz ALTOGEN AG Vollzeit

    In 10 years, the Efor Group has reached the leading position in Life Sciences consulting with strong, synergic and strategic acquisitions. Our ambition is to build a global leading position of our market in 2028.In Switzerland, we work with 300 experts who support our customers on their various projects in the French-speaking and German-speaking parts of the...

  • Finanzcontroller:in

    Vor 3 Tagen

    Basel, Basel-Stadt, Schweiz Hays Vollzeit

    Für unseren Kunden in Basel suchen wir für 12 Monaten einen Finanzcontroller im Asset Management.AufgabenErstellung der Hochrechnungen, Planrechnungen sowie der Business-Pläne für Group Asset ManagementVerantwortlich für die Erstellung des Management Informations-Systems (MIS) mit den entsprechenden Kennzahlen und Treibern sowie den zur Steuerung...

  • SAP FI/CO Senior Consultant

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz BROMsolutions AG Vollzeit CHF 100'000 - CHF 120'000 pro Jahr

    SAP FI/CO Senior Consultant (m/f) Region: Zürich Pensum: 100% Job-ID: Your challenge Play a key role in large-scale client engagements primarily related to SAP programme and SAP enabled business transformation, as well as conceptual advice throughout the implementation cycle Identifying key client process and technology issues and recommending solutions As...

  • SAP Logistics Manager

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz BROMsolutions AG Vollzeit CHF 100'000 - CHF 120'000 pro Jahr

    SAP Logistics Manager / SAP S/4HANA (m/f) Region: Zürich Pensum: 100% Job-ID: Your challenge Work in interesting SAP business transformation programs Analyse service processes and advise on the design and implementation of SAP services in SAP SD, SAP MM and SAP PP VC solutions Lead the day-to-day activities of SAP advisory engagements and be responsible for...

  • Global Clinical Program Manager

    vor 1 Tag

    Basel, Basel-Stadt, Schweiz Coopers Group AG Vollzeit CHF 100'000 - CHF 120'000 pro Jahr

    Global Clinical Program Manager (m/f/d) end date: one-year-contract location: Basel and Rotkreuz (CH) work model: Contracting Your Key Responsibilities: Planning expert in Clinical Operations Program Leadership and responsible for partnering with key stakeholders and CDMA (Clinical Development & Medical Affairs) functions to manage CDMA related...