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.

GxP Global Statistics and Data Science Quality Specialist

Your Job

You will be responsible for supporting the regional QA manager in the daily management of the Global Statistics Data Science (GSDS) quality system, its implementation and optimisation.
  • Helping in the preparation of processes to ensure the compliance of the local Quality Management System with the GxP (mainly GMP, GCP, GLP and GAMP), regulatory/legal and clients’ requirements.
  • Monitor quality metrics (KPI) and help to prepare quality management reviews.
  • Monitor compliance with PharmaLex training standards and documents.
  • Participate in the writing and reviewing of procedural documents, participate regular reviews and updates .
  • Participate in internal, external and company vendor audits.
  • Preparing corrective and preventive action  documentation.
  • Preparing non-conformities and complaints.
  • Quality oversight and quality control on software (SW) validation and IT infrastructure projects for process set up.
  • Quality alignment on filing of company documents and information for the Quality Assurance and also for Statistics/Pharmacometrics/Data Science, SW development and validation and IT infrastructure projects as applicable according to internal Quality management System , ISO, GxP and/or clients requirements.
  • Monitoring and centralization of project-specific quality documentation during the project and gathering the essential quality documents to send back to the customer at the end of the project.
  • Administrative support related to quality management projects and activities.
  • Participate and execute internal and vendor audits to ensure good application and performances of the quality system.
  • Participate in external audits and ensure their follow-up.
  • Actively participate in Quality System harmonization efforts with PLx US and PLx India for the harmonized GSDS quality system.

Your Profile

  • Master’s qualification in a scientific domain.
  • 1-2 years of experience in a GxP-compliant Quality System.
  • Basic IT knowledge.
  • Fluency in English. Fluency in French would be a plus.
  • Curiosity, Anticipation and Strictness.
  • Autonomous, concentrated and high-quality work.
  • Ability to work in a team.
  • Sense of responsibility.
  • Full ethical person.

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.

For further information please don’t hesitate to contact us:

Jorge Castillo
Senior Specialist, Corporate Talent Acquisition


Agencies only by prior agreement for the specific job opportunity.