Our client, who works with leading pharmaceutical organisations to support them with the development, processing and manufacturing of protein therapies are currently seeking the expertise of a CQV Engineer.
Essential Duties and Responsibilities for this role include, but are not limited to, the following:
- Ensure correct and state of the art Qualification/Validation approaches, to establish the Validation Plan and be accountable for all cGMP decisions taken during the Validation of our projects starting with the Design Qualification step and ending with the establishment of the Validation Summary report.
- To ensure oversight of the qualification (IQ, OQ, PQ) and validation (PPQ, CV, PV) activities.
- Responsible for writing, reviewing and approving validation documents (URS, Risk & impact Assessment, VMP, design review qualification, test matrices, IQ/OQ/PQ Protocol, IQ/OQ/PQ Report,…).
- Organise, execute and document CQV testing.
- Support during system/installation start-up in function of CQV test activities
- Responsible for the implementation of the validation guideline and SOP for the processes & equipment (Validation life-cycle process, Qualifications, Process Validation).
- Responsible for the implementation of adequate validation strategy in compliance with FDA, EMEA and International quality standards.
- Responsible for assuring inspection readiness – regarding Validation
- Responsible for smooth handover from PPQ/Process Validation to production (Training, SOPs etc.)
- Assistance with requirements of Equivalence Reports, Equipment Family Reports, etc.
- Build a strong partnership with key stakeholders; both internal & external
- Expert in the field of quality/validation activities & control tests, cGMP and EMA/FDA
- Understanding of good practices in biopharmaceuticals, current Industry standards, regulatory requirements and Authority expectations regarding CQV.
- Experience in Pharmaceutical production environment, process validation, equipment validation. Experience in cold chain is a plus.
- You have a good Comprehension and understanding of technical installation, PID, equipment and buildings for the Life Science Industry.
- Understand quickly the characteristics and the mechanism of a broad range of production equipment and process including their potential impact on product and patient safety.
- Use a risk-based approach for problem solving and prioritization of tasks.
- Have a quality and compliance mindset through the validation activities.
- You have a field experience with:
- System start-up and CQV
- Project scheduling
- Change management
- Project document management
- Strong communication, organizational and influencing skills to work transversely.
- Good team player in order to succeed in the validation project, who can also work independently.
- You speak and write fluent English, Dutch and/or French
- Must work independently with minimal supervision and schedule tasks in time so the project can be delivered on time.
- Due to covid restrictions we are ideally looking for a candidate based in Belgium, if this is of interest to you then please apply today!
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta part of QCS Staffing does not sponsor Visa applications.
CLEAN & BLACK UTILITIES PROCESS ENGINEER- BRUSSELS- 12 MONTH CONTRACT Our client, who works with leading pharmaceutical organisations to support them with the development, processing and
Validation Lead- Brussels - 12 months contract Our client, who works with leading pharmaceutical organisations to support them with the development, processing and manufacturing of protein
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