Qualification Expert with Regulatory Compliance
vor 1 Monat
D-ploy is an innovative IT and Engineering Solutions company with a strong presence in the EMEA region and the USA. We strive to deliver exceptional services and solutions to leading industry clients by fostering trusted partnerships and optimizing IT productivity.
We are seeking a skilled and solution-oriented individual to join our dynamically growing and international organization. As a Qualification Expert, you will play a vital role in creating value where IT matters.
Key Responsibilities:- Develop and execute computer-based system qualification deliverables, including project plans, HLRA, URS, QPlan, IQ, OQ, PQ, ERES assessment, and Verification, in a pharmaceutical environment.
- Review qualification deliverables generated by project team members.
- Migrate computer-based lab equipment systems, including Operating Systems and data.
- Provide assistance to onsite lab IT supporters in troubleshooting and system configuration.
- Collaborate with the Service Coordinator and Service Delivery Manager to ensure project management processes are followed to complete projects within timeline and budget.
- Act as a Subject Matter Expert for qualification purposes and Point of Contact for regulatory inspections and audits.
- Support and deputize colleagues onsite.
Requirements:
- Experience in big pharma, document creation, GxP, and IO OQ PQ.
- Knowledge of qualification processes and Computer System Validation concepts.
- Understanding of 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.
- Able 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.
- Effective in gathering feedback and implementing improvements.
- Self-responsible, self-organized, and flexible individual.
- Ability to multitask and handle changes in requirements or schedule.
- Willingness to work at different customer locations.
- Fluency in English and German (spoken & written).
- Candidates must provide a recent Criminal record extract.
Benefits:
- Diverse 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).
- Free refreshments in our D-ploy offices.
- Insurance Benefits.
- Fishing for Friends program – our referral program.
- Opportunities for further development and professional advancement.
- Friendly and international working environment.
- Competitive salary and various benefits.
Are you a good match for this role?
We are interested in speaking with individuals who believe they have the skills and experience required for this position. You can apply through our website or by contacting our recruitment team.
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