VALIDATION ENGINEER QA - CDI
Start People Inhouse Takeda
LESSINES, BE
1 dag geleden

Description

New Challenge as VALIDATION ENGINEER for TAKEDA LESSINES !

You have a few years of experience in Validation or Quality in a pharmaceutical industry?

You have already worked in Validation or Engineering Functions ?

You have good knowledges about Quality pillars (QA, QC, Systems and Compliance)?

You have good teamwork skills and critical thinking ?

We have the right job for you !

Read our Validation Engineer Offer !

Summary

The Quality Validation Engineer II is responsible to perform the quality oversight of validation activities including process, product, cleaning, equipment, material, shipping, IT and computerized systems validation at the Lessines facility.

She / He will have authority to make decisions in her / his projects, and if needed is supported by a Quality Validation Senior Engineer or Quality Validation Lead.

Essential Duties and Responsibilities

  • Review / approve validation documentation from projects (RA, DQ, IQ, OQ, PQ, PPQ) and associated specification documents (URS, Functional / Design Specification) with a priority to complex projects.
  • Coach of Quality Validation Engineers I, or external contributors review of documents prepared by Quality Validation Engineers I or external contributors
  • Review periodic evaluation maintaining the accurate validation state of processes, facilities and systems ensuring compliance to procedures and regulatory requirements
  • Provide quality guidance for the development strategy and risk analysis related to the validation
  • Provide support in quality-related issues, including GMP regulations, compliance with internal SOPs, and all aspects of safe, reliable and consistent operation of the system with the support of a Quality Validation Senior or the Quality Validation Lead, if needed.
  • Company

    In Lessines, TAKEDA is producing medicines for immunologic and hematologic therapies. The plant’s main activity is the purification of plasmatic immunoglobulin for the treatment of primary immunodeficiency, as well as the treatment and conditioning of coagulation factors for hemorrhagic troubles (hemophilia A & B).

    As a production site, the plant in Lessines is functioning 24 / 7 and employs 950+ personnel members.

    Profile

  • Knowledge of regulations related to validation activities in pharmaceutical industry
  • Exposure and / or knowledge of Validation and Engineering functions.
  • Experience about Quality pillars (QA, QC, Systems and Compliance) including cGMP regulations.
  • Strong oral and written communication skills with teams, peers, global partners
  • Teamwork skills. Develop and maintain good working relationships with customer groups and support an positive environment of teamwork and collaboration
  • Critical thinking and demonstrated problem solving skills.
  • Good Organizational skills
  • Assertivity skills
  • Offer

    We offer you a permanent contract in one of the largest and leading companies in the Pharmaceutical Sector : TAKEDA

    Here, the benefits to work for the company TAKEDA as VALIDATION ENGINEER :

  • Atractive salary
  • Lunch voucher
  • Refund in the travel expenses (go & return)
  • Insurances
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