CSV Analyst

21 Apr 2024

Vacancy expired!

Position: CSV AnalystWork Location: Boston MA - Onsite Duration: 12+months

Job description:

Conception, planning and performing of

Computer Systems Validation (CSV) in the

regulated environment (Pharma, Medical Devices, Biotech)Advisory and support of application owners to build and maintain

GxP conform systemsSupport and consulting during projects handling

GxP critical computer systemsImplementation of qualification / validation activities within projects of new and existing computer systems according to our client requirementsConception and implementation of Raw-Data-Handling systems and solutions (

Data Integrity)Computer systems according to internal Software Development LifecyclePerforming internal and external

CSV trainings

Position Requirements University degree in Informatics, Quality, Engineering or another relevant disciplineAt least 2-3 years of experience in

validation of

GxP relevant IT systems such as ERP, MES, LIMS or Quality SystemsWorking knowledge of national and international regulations and standards, eg.

GAMP5, ISO 9001, ISO 13485, ISO 62304, FDA QSR, 21 CFR Part 820, Part 11Analytical and structured working style; strong attention to detailAbility to effectively work as part of a multidisciplinary, international teamHands-on personality, with flexibility and dedication to maximize our client`s value?

Thanks & Regards

ShivaSenior Specialist – Talent Acquisition

Ampcus IncDirect:

Email ID:

14900 Conference Center Dr, Suite 500,Chantilly, VA 20151

  • ID: #49741524
  • State: Massachusetts Boston 02109 Boston USA
  • City: Boston
  • Salary: $60 - $70
  • Job type: Contract
  • Showed: 2023-04-21
  • Deadline: 2023-06-16
  • Category: Et cetera