QA, Qualification & Validation Specialist
QA, Qualification & Validation Specialist
QA, Qualification & Validation Specialist
QA, Qualification & Validation Specialist
Batterman Consulting Basel AG
Pharma, Medizintechnik
Solothurn
- Art der Anstellung: Vollzeit
- 81.000 CHF – 117.000 CHF (von XING geschätzt)
- Vor Ort
QA, Qualification & Validation Specialist
Über diesen Job
Your area of responsibility
Your profile
Your advantages
- Responsibility for the validation and qualification of cleanrooms, machinery and production processes
- Planning, implementation, documentation and approval of DQ, IQ, OQ and PQ - in compliance with applicable GMP and ISO regulations
- Organization and implementation of cleanroom qualifications, including monitoring of relevant environmental parameters (e.g. temperature, humidity, particle counts) in collaboration with external partners
- Ensuring and continuously developing quality and compliance standards in the cleanroom context
- Creation, maintenance and training of SOPs (Standard Operating Procedures) for all relevant processes in the cleanroom
- Support with CAPAs, change control and deviations
- Processing customer complaints and preparing and accompanying internal and external audits
Your profile
- Completed apprenticeship as a laboratory technician (biology, chemistry) or scientific studies
- Experience in validation and qualification, e.g. laboratory equipment (instruments, washing machines, scales, refrigerators) or process systems (DQ, IQ, OQ, PQ)
- Good knowledge of the relevant GMP and ISO standards
- Experience in quality assurance with CAPA, changes, deviations and complaints
- Experience in the implementation of process validations and the creation of corresponding documentation is an advantage
- Independent personality, with an exact, structured and organized way of working
- Good communication skills and a sense of humor
- Very good written and spoken German and English. French is a big plus
Your advantages
- A versatile and varied position in a highly modern and growing area
- Financial support for further education and training
- Good career prospects and the opportunity to take on further responsibility
Our customer
Our client is a leading company in the pharmaceutical industry. High-quality products for customers in the pharmaceutical and biotechnology sectors are produced and filled in the clean room using state-of-the-art production facilities. In order to meet the high requirements of the GMP environment in the future, the quality assurance department will be further expanded. Place of work: Solothurn region
Our client is a leading company in the pharmaceutical industry. High-quality products for customers in the pharmaceutical and biotechnology sectors are produced and filled in the clean room using state-of-the-art production facilities. In order to meet the high requirements of the GMP environment in the future, the quality assurance department will be further expanded. Place of work: Solothurn region
