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.
- 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
- 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%
- Technical Degree (Engineering, Chemistry, Informatics)
- PhD in technical fields
- IT background, passion for Informatics and Quality
NICE TO HAVE
- Fluent English (at least B2/C1 Level)
If interested, please send your resume in English language.
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