pharmalex_job_career



We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity. Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.

 

CSV Specialist


Your Job

  • Gain sufficient knowledge of the local CSV procedures
  • Provide support with qualification of infrastructure:
    • Follow up of the deliverables for Operational Phase such as Change Control, Incidents (IT), Configuration Management (Make sure that all documents are signed by the required people and filed in the proper location)
    • Perform Qualification (IQ/OQ of Qualified Statistical SW)
    • Internal Audit for infrastructure.
  • Support the validation of custom software (GAMP 5 category 5)
    • Establish the list of deliverables (quality), help in completing URS with regards the regulations, help in the set up of the Risk Matrix, update the requirement tracevaility Matrix
  • Assist in performing GAP analysis on current status versus regulation requirements (such as Electronic Signature solution implementation)
  • Review and approve IQ and OQ protocols & reports, PQ protocols & reports
  • Write, review and approve validation plans and validation summary reports
  • Support the process of validation of statistical projects
  • Assist with (automated) testing of custom build software
  • Review of CSV specific SOP’s and Templates


Your Profile

  • At least 1 year experience (ideal 3 years) in a computer systems validation role in the pharma sector
  • Knowledge of specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11)
  • Autonomous working manner
  • Ability to deliver high quality documentation work
  • Good document management skills because most work will be documentation-based (administrative assistant)
  • Fluency in English.


We offer

  • Opportunity to conquier exciting and varied challenges alongside a talented team
  • Option for flexible working hours
  • Open and collaborative organisational culture with emphasis on knowledge-sharing
  • Business interaction with nearly all branches of the company across 5 continents
  • Broad range of initiatives for personal development and professional training.



If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.

Agencies only by prior agreement for the specific job opportunity.