Csv Consultant

With more than 1500 employees, 45+ nationalities and
30 subsidiaries all over the world (Europe, Asia and the Americas), joining PQE means join a
multicultural and challenging company with many
local and international projects, and colleagues from all over the world.

Due to a constant growth, PQE is looking for a
CSV Senior Consultant to implement our new team in
Buenos Aires, Argentina.

In this full-time role, the CSV Consultant will participate in Computer System Validation projects for clients in the Pharmaceutical and Medical Devices Industries.

The Consultant will work alone or more frequently as part of multidisciplinary teams (either as leader or team member), depending on the nature and complexity of the project.

• Resolution of fundamental Computer System Validation compliance issues on assigned projects
• Writing, reviewing and executing computer validation documentation
• Primarily accountable for the validation of compurterized systems, in accordance with GAMP5 and V-Model (USR, Function Specification, IQ/OQ/Protocol/Report/Testing, Traceability Matrix, Validation Report)
• Very good knowledge of Data Integrity Assurance according to EU GMP Annex1, US FDA Annex 11 and relevant predicate guidances
• Capable to assess electronic/paper records aiming to identify Data Integrity gaps with Risk-Based Approach and suggest the most appropriate mitigation/remediation actions
• Ensure all projectrelated issues and deviations are recorded, approved and dispensed accordingly (including ensuring proper deviation report preparation and approval)
• Preparation of project and life‐cycle reports and review/approve all other documents to ensure compliance with SOP
• Ensure all project and lifecycle documents achieve the goal of traceability, and these are all retained in the document repository (Document Navigator) and approved following the prescribed SOP

• 
  English full proficiency (any additional language will be considered a plus)
• Availability to travel domestically and internationally up to 60%
• Knowledge of
  regulations and guidelines applicable to computerized and automated systems (GAMP, 21 CFR part 11,)
• Ability to work as a team player in a consulting environment

Our collaborators are engaged, developed, challenged and
well-rewarded for performance. We recognize the
importance of leadership at all levels of our organization to succeed in a challenging business environment, and we are committed to
providing practical processes and programs to identify, develop and inspire all our current and future leaders.

• Inglés (Obligatorio)

• 75 % (Obligatorio)