CSV Engineer H/F/X

Beschrijving van de functie

Contracting - Brabant Wallon

Writing, reviewing and approving of validation plans and validation summary reports Reviewing and approving of design documentation (TCD, ERES, URS, DQ, ...) Reviewing and approving of qualification protocols and reports (IQOQ & PQ) Writing and reviewing of Periodic Review Reports (PR) Reviewing and approving of CSV specific documentation (inventory, ...) Reviewing of CVS specific SOP'S and Templates Ensure the proper execution of the qualification and validation activities with respect of the GSK validation methodology to maintain the validated status of automated and computerized systems. Ensure QA activities on quality systems (CAPA, Deviation, Change Control, ...) related to automated and computerized systems. Support team and management during internal and external audits

Jouw profiel

CGMP and specific regulations and guidelines applicable to computerized and automated systems (GAMP, Eudralex Vol 4 annex 11, 21 CFR part 11, .) Validation practices and guidelines (life cycle approach, ICH, ASTM E2500, .) Quality oriented. University (Master) degree in Sciences / Biological Engineering (e.g. Pharmacist / Master in Sciences / Bio Engineer) Certification in computer system validation or equivalent is a plus. Experience in a computer systems validation role Experience with SAP, MS Office Fluency in French & English

Taalvaardigheden

• Frans (troef)

  • Begrijpen : Vaardig - (C1)
  • Schrijven : Vaardig - (C1)
  • Lezen : Vaardig - (C1)
  • Spreken : Vaardig - (C1)

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