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Computerized System Validation Engineer

ALIGN TECHNOLOGY

  • ogłoszenie wygasło 2 dni temu
  • umowa o pracę
  • pełny etat
  • specjalista (Mid / Regular), młodszy specjalista (Junior)
  • praca hybrydowa
  • rekrutacja zdalna

ALIGN TECHNOLOGY

Bierutowska 57-59

Psie Pole

Wrocław

Technologie, których używamy

System operacyjny

Twój zakres obowiązków

  • Represent Quality function as Global CSV Engineer and support system compliance

  • Assist in managing Global System Inventory

  • Manage all aspects of Computerized System Validation

  • Ensure computerized systems are appropriately validated

  • Provide implementation or upgrade project teams with (expert) computerized systems validation (CSV) guidance

  • Help project teams define appropriate computerized systems validation strategies.

  • Prepare or review all levels of validation documents (internal or external) including: Validation Plans, User Requirement Specifications, Validation Reports etc.

  • Ensure all project and lifecycle documents achieve the goal of traceability, and these are all retained in the electronic document management system and approved in accordance with the applicable SOP

  • Provide training on Computerized System Policies, SOPS, industry regulations trends and “hot topics” to project team, members, system owners and users

  • Support Global Computerized System Validation during internal/external audits

  • Provide timely support to local QMS teams during internal/external audits and inspections in respect to document/data requests

Nasze wymagania

  • Minimum 1-2 years’ experience in Computerized System Validation

  • Minimum 2-3 years’ experience in highly regulated life sciences industry (biotech, medical device or pharmaceutical organization) and maintains a broad regulatory understanding

  • IT skills and demonstrated understanding of hardware and software platforms

  • Can work flexibly to carry out expected responsibilities and assigned tasks

  • Business level and fluent English speaker and writer

  • Good knowledge of general Quality Management, 21CFR Part 11 and ISO 13485

  • Has a knowledge of GAMP, risk based approach to validation and a good understanding of electronic records and signatures

  • Experience working across cross-functional global teams

  • Benefity

  • prywatna opieka medyczna

  • dofinansowanie nauki języków

  • ubezpieczenie na życie

  • owoce

  • zniżki na firmowe produkty i usługi

  • parking dla pracowników

  • dodatkowe świadczenia socjalne

  • karty przedpłacone

ALIGN TECHNOLOGY

At  Align Technology, we believe a great smile can transform a person’s life, so we create technology that gives people the confidence to take on whatever’s next. We revolutionized the orthodontic industry with the introduction of the Invisalign system, and we have never lost sight of that spirit of innovation. Our diverse and collaborative teams are constantly pushing the boundaries of what’s possible.

Ready to join us?

The Computerized System Validation Engineer, role forms part of the Global QMS Team, reporting to theManager Global Computerized Systems Validation. This role will be responsible for the validation of computerized systems, control of computerized systems at Align according to applicable SOPs and regulations in multi-disciplinary teams.

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