Collabera Poland | Digital Engineering and Talent Orchestration

Quality Engineer Specialist

8 Years Experience : in Poland , in Warsaw
  • Post Date: July 20, 2022
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Job Description

Type : Contract

Experience / Qualification:

  • Minimum experience of 8 years and above in the above role and relevant to Pharma industry.
  • Responsible for review and approval of Computer system validation deliverables as per applicable IT QMS SOPs.
  • Responsible for overall regulatory compliance of computerized systems used for GMP purposes.
  • Responsible to conduct training in the areas of CSV and Data Integrity to facilitate validation activities.
  • Responsible to support vendor assessment of IT system suppliers & compliance.
  • Shall be able to communicate with business, site IT, CSV and GIDC team in English and local site language.
  • Must have good knowledge of Regulations (i.e., 21 CFR Part 11, Annex 11, GMP), GAMP, CSV, QMS and documentation.
  • Must have good knowledge of enterprise application used in Pharma industry, laboratory systems and manufacturing equipment automation with PLC/SCADA/IPCs.
  • Must have worked on various aspects of CSV/QMS.
  • Must have participated in regulatory inspections like USFDA, EU, WHO etc. & their compliance.


Benefits :

  • Private healthcare
  • Multisport Card
  • Excellent career opportunity for growth in MNC


Min Experience in years : 8 years

Max Experience in years :8+ years

Recruiters Name (Full Name) : Usha Garnepudi

Recruiters contact number : +48 22 104 92 81

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