CSV Consultant
woj. lubelskie

Job location: Poland

Standard working hours: Monday- Friday
9.00 am – 5.00 pm

 

Responsibilities:
  • Responsible for maintaining validated state of multiple, concurrent systems - Author, review, approve applicable CSV deliverables
  • Support CSV activities in a risk based model, during project and operational phases of a system
  • Provide support on inspection/audit readiness. Participate in mock audits and coordinate preparation for the same
  • Authoring/contributing/reviewing system specific SOP/WI
  • Handle end to end change control process
  • Follow up/support deviation process and creation of Deviation Report/CAPA
  • Make sure all project activities are carried out per the regulations, applicable SOP’s and policies
Requirements:
  • At least 4 years of experience in CVS processes,
  • Well versed with Pharma regulations – GAMP, GxP, 21 CFR part 1,
  • Knowledge about Infrastructure qualification, system retirement activities, data migration,
  • Excellent knowledge of Risk assessment – System and Functional,
  • Fluent in English, Dutch: good to have but not must,
  • Quick learner and adaptable to learn new processes, concepts, and skills,
  • Strong attention to detail with a desire to deliver accurately, efficiently and to a high standard,
  • Highly motivated with the ability to thrive in a fast-paced, high energy, and demanding team-oriented environment,
  • Experience working in international environment is nice to have.
We offer:
  • Opportunity to be part of a rapidly expanding global organization with irreproachable reputation.
  • Pleasant and inspiring working atmosphere.
  • Professional development and clear career path.
  • Training & development opportunities.
  • Competitive salary with cafeteria benefits.
Prosimy o dopisanie klauzuli: Wyrażam zgodę na przetwarzanie moich danych osobowych zawartych w mojej ofercie pracy dla potrzeb niezbędnych do realizacji procesu rekrutacji (zgodnie z Ustawą z dnia 29.08.1997 r. o Ochronie Danych Osobowych; tekst jednolity Dz. U. z 2016 r. poz. 922 z późn. zm. ). Jednocześnie oświadczam, że zostałem/am poinformowany/a o dobrowolności podania danych osobowych oraz prawie dostępu do treści swoich danych i ich poprawiania.

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