Qualification Expert
vor 1 Woche
D-ploy is a leading IT and Engineering Solutions company with a strong presence in the EMEA region and the USA. We are seeking a highly skilled Qualification Expert to join our team.
Key Responsibilities:- Develop 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.
- Review qualification deliverables generated by project team members.
- Migrate computer-based lab equipment systems, including Operating System and Data.
- Provide technical support to onsite lab IT supporters in troubleshooting and system configuration.
- Assist the Service Coordinator and Service Delivery Manager in project management 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.
- 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 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 and German (spoken & written).
- Candidates must provide a Criminal record extract not older than three months.
- 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.
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