Kelly Scientific is looking for its pharmaceutical partner localized in Switzerland a Quality Validation Specialist - Permanent position.
QUALITY VALIDATION SPECIALIST - Permanent position - 100%
* Main quality partner of the validation team.
* Responsible for quality aspects during the validation activities.
* Quality validation representative for both validation routine activities and projects.
* Ensure quality of information within validation documentation in respect to current regulations and internal procedures.
* Involved in the audit GMP as quality partner of the validation team.
* Responsible for reviewing and approving validation protocols, reports, procedures and other related documents related to cleaning, sterilization, equipment, process, HVAC, utilities, Computerized systems to ensure compliance to internal procedures and regulatory requirements.
* Review and approval of routine monitoring protocols (CIP, SIP, Temperature control unit)
* Define and challenge, with the validation team, validation approaches to be compliant with current regulations
* As the Quality validation representative in projects: ensure the quality validation aspects are respected within project, raise the compliance gaps to the manager
* Evaluate and approve deviations related to validation protocols in order to guarantee proper tracking/documentation of the incidents and identification of corrective actions
* University degree in Bioscience / Engineering / Biotechnology
* At least 2 years of experience in quality biotechnology manufacturing and/or pharmaceutical industry
* Experience in validation topics (CIP, SIP, HVAC, Process, utility, Computerized system)
* Fluent in French
* Professional English level is required as most of documents to review are in English
* Good knowledge of FDA, EMA, ICH regulations and Quality system standards.
* Ability to interact with all types of personalities in an effective and diplomatic manner.
* Critical thinking and demonstrated problem solving / root cause investigation skills
* Good analytical skills and ability to simplify the complex.
* Good organizational skills and continuous improvement mind.
* Autonomous, reactive and flexible