Beschreibung
Sehr geehrte Damen und Herren,aktuell suchen wir für einen unserer Kunden in Hamburg Unterstützung in der CSV bzw. im tech. writing.
CSV Engineer / Technical writer (m/f/d)
Responsibilities:
- Perform computer system validation activities according to the latest regulations (CFR part 11, EudraLex Annex 11, GAMP 5, data integrity etc.) in JnJ Norderstedt Site for systems and applications in scope of JJT.
- Preform CSV requalification program as well as validation planning and resourcing for all Application lifecycle management projects.
- Knowledge of validation/computer validation methodologies and principles to perform CSV on a large variety of systems.
- Co-ordinate and execute data integrity activities (assessment, reports, mitigations, trainings) at QC, Production and IT departments.
- Reviewing, approving and signing off protocols, reports, project change controls for CSV projects.
- Accountable for scheduling, tracking, reporting and achieving project deadlines.
- Updating and initiating new SOPs related to data integrity and CSV.
- Support resolution and management of Compliance activities for IT department such as observations, NCs, CAPAs
- Assist and advise on CSV aspects for internal and external projects.
- Participates in internal and external audits and inspections where required.
- Conducting and participating in risk assessments, root cause analysis and investigations related to CSV.
- Participating and collaborating in cross-functional project team environments
- Discrepancy investigations/validation deviations
General skills:
- Experience at GXP environment
- Strong attention to detail and accuracy.
- Excellent communication skills and ability to work in a team
- Quick and independent ability to learn
- Strong collaboration, communication, presentation and influencing skills required.
Requirements:
- A minimum of a BA/BS/Eng Degree or equivalent is required
- Experience in CSV 1-3 years
- Fluent English and German skills (writing/reading/speaking)
- Excellent skills with Microsoft office
- Act independently, typically only receiving oversight and direction for key decisions points
- Project management experience (is a plus)
- Experience interfacing with global or regional teams
- Ability to think strategically as well as having a very good attention to detail
- Ability to work in a remote team, other team members being based in different sites & countries worldwide
- Strong sense of urgency, ability to react very quickly and to work long hours during peak activity, ability to shift seamlessly as priorities change
Bei Interesse freue ich mich auf Ihre Rückmeldung!
Danke und Beste Grüße
Tobias Laumeister
t.laumeister(a)realstaffing.com