They are looking for somebody to assist them on their technology transfer project.
If you are an experienced Validation engineer with Sterile experience as well as experience executing full life-cycle of validation cycles (IQ/OQ/PQ), then this role is perfect for you.
The responsibilities of the successful validation engineers will include:
- Defines principles of equipment validation (related to technology transfer project)
- Monitors and implements the changes of the GMP and corporate regulations related to validation in the site
- for compiling the Equipment Validation Master Plan
- for the preparation and acceptance of system-level impact studies
- for approval of IQ / OQ certifications and PQ procedures and final approval of qualification reports
- for preparation of summary report for the qualification
- for archiving the qualification documentation
- Supports and assists other departments in validation activities
- Responsible for supporting validation processes during Change Control
- Participates in internal and external audits.
- Supervising the implementation of validation in accordance with GMP and company regulations
- Technical and quality supervision of the validation process of the equipment involved in project
- Advanced level degree (graduate chemist, chemical engineer, biologist or equivalent)
- GMP and technical validation skills
- Fluent written and spoken English
- High user level computer skills (Word, Excel)
- Good communication and problem solving skills, accuracy, precision
- Previous experience of drafting and executing protocols (IQ/OQ/PQ)
- High level of experience with validation master plan (VMP)
- Previous experience of working within a cGMP/Hungarian regulated environment
- Advantages: Pharmaceutical work experience, validation work experience
The candidate must have the rights to work in the location stated in the job advert.
Please note, Quanta Consultancy Services does not sponsor Visa applications.
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