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job location Job Location:

Adelaide, Australia

 

CSV Consultant

Requested Languages:

English
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job at pqe

Due to a constant growth, PQE is looking for a new CSV Consultant (Pharmaceutical Area). The Resource shall be involved in CSV Compliance projects (Pharma), supporting our Customer located in Adelaide, Australia; the Resource shall also report directly to the Validation Director and contribute to the growth of the CSV team, enhancing PQE services in Pharmaceutical area.



    JOB TASKS
  • Resolution of fundamental Computer System Validation compliance issues
  • Align with e‐Compliance on project management and life cycle documentation deliverables for GxP relevant projects
  • Ensure all project related risks are well managed and deliverables are validated (for GxP)/tested (for non‐GxP) in accordance to SOPs and the associated CSV requirements
  • Ensure completeness and consistency of project life cycle documentation
  • Ensure all project related issues and deviations are recorded, approved and dispensed accordingly (including ensuring proper deviation report preparation and approval)
  • Collect and manage the user requirements from various departments into specifications and details, including support to establish user requirements, IQ/OQ/PQ documentation(i.e. protocols, acceptance criteria, and close out reports)
  • Prepare project and life‐cycle reports and review/approve all other documents to ensure compliance with SOPs
  • Ensure all project and lifecycle documents achieve the goal of traceability, and these are all retained in document repository (Document Navigator) and approved in accordance to the prescribed SOPs
    REQUIREMENTS
  • English language proficiency
  • 5 years’ experience in Pharmaceutical Companies, running activities such as Equipment validation, Computerized Systems Validation, Quality Control
  • good knowledge about the whole cycle of the manufacturing process
  • Knowledge of GMPs requirements
  • Knowledge of ALCOA and GAMP practices
  • Willingness to travel up to 75%
    EDUCATION:
  • Technical Degree (Engineering, Chemistry, Informatics)
    NICE TO HAVE
  • PhD in technical fields
  • IT background, passion for Informatics and Quality
    LANGUAGES:
  • Fluent English (at least B2/C1 Level)

Full-Time Job

If interested, please send your resume in English language.
Our collaborators are engaged, developed, challenged and well-rewarded for performance. We recognize the importance of leadership at all levels of our organization in order 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.


job at pqe