Oferta pracy

Senior Qualification Engineering Systems

Avenga PolandO firmie

Rekrutacja zdalna

Rekrutacja zdalna

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Rekrutacja zdalna
  • Warszawa, Polska
    Warszawa, mazowieckie
  • Ogłoszenie wygasło 17 dni temu
  • Umowa o pracę, Kontrakt B2B
  • Pełny etat
  • Starszy specjalista (Senior)

Avenga Poland

Warszawa

Warszawa

Senior Qualification Engineering Systems SpecialistNumer ref.: APD/SQSS/WAW/ŁD/11/20

RESPONSIBILITIES:

  • Reviewing and approving qualification deliverables such as qualification plans, protocols and reports as well as deviation/CAPA/change documentation
  • Preparing qualification plans including scope of activities
  • Creation of criticality/compliance assessment and risk analysis accordingly to the scope of qualification service
  • Monitoring and supervising systems’ documentation related to qualification activities
  • Leading activities according to current GxP regulations, standards and internal processes & guidelines
  • Supervising qualification status of engineering systems and equipment liaising with quality assurance / compliance department
  • Initiating corrective and preventive actions related to qualification activities
  • Developing standard operational procedures accordingly
  • Liaising with computerized systems’ validation representatives to adjust the scope of qualification and validation (CSV) activities accordingly, including providing respective risk analysis
  • Analysing data from qualification / validation activities and providing conclusions, reports and proposed further actions as well
  • Reporting status of tasks and areas covered to maximize efficiency in a team
  • Notifying about issues and risks for business, quality and project

 

REQUAREMENTS:
  • At least 3+ years experience in the field
  • Implementation and working with requirements according to cGMP i FDA
  • Maintenance and support of engineering systems and equipment under global inspection agencies,
  • Direct presentation, defence and building strategy to regulated inspection authorities, e.g GIF / FDA
  • Working in pharmaceutical / biopharmaceutical company with qualification processes
  • Leading, preparing and execution of qualification activities such as DQ, IQ, OQ i PQ, including qualification for clean media, automated systems as well as equipment
  • Quality maintenance and support of regulated applications.
  • Independent research and problem solving, good work and time organization, efficient work under pressure and right prioritization
  • Correct and proactive communication and documents writing in English / level B2/C1

If you are interested, please read our information clause and send your application by clicking on “Aplikuj” button.

Please include in your application the following consent:


I agree to the processing of my personal data provided by me, not mentioned in art. 221 § 1 of the Labor Code, or other specific provisions applicable pursuant to art. 221 § 4 of the Polish Labour Code, in order to recruit by the Administrator - IT Kontrakt  Sp. z o.o. with registered office in Wrocław, ul. Gwiaździsta 66, 53-413 Wrocław, for the position Senior Qualification Engineering Systems Specialist

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