QA Validation Expert

QA Validation Expert (FR/EN) vacancy for our Neuchatel based client in the pharmaceutical sector.

As QA Expert you will report directly to the QA Manager and be responsible for compliance and quality oversight and validation aspects related to laboratory projects.
The QA Expert is the representative for both routine GMP (Good Manufacturing Practices) activities and project. He/she must ensure the quality of information reported within the various systems and documentation with respect to current guidelines, compliance and regulatory requirements.
Your tasks:

• Review and evaluate change requests according to procedures, GMP requirements and licenses
• Act as the Quality partner for QC Laboratory Projects
• Acts as Quality Representative facility projects to support the quality system deployment and application to meet the current
• Execute guidelines and Regulatory cGMP requirements in the respective Quality area
• Responsible for quality aspects during the validation activities: review validation deliverables (i.e. validation plan, protocols, reports, URS, design qualification, risk assessment...),
• Define and challenge, validation approaches to be compliant with current regulations
• Lead and/or review deviations in the framework of events during the project (i.e., Trackwise) to verify acceptability and adherence to standard procedures and regulatory requirements.
• Conducting or approving the relevant investigations, impact assessments (related to impact on concerned. equipment/product/material) and definition of relevant CAPA.
• Provide feedback on projects activities using proactive communication.
• Prepare, evaluate, and approve controlled documentation revision.
• Report out of findings/issues to functional leaders and higher management as needed.

Your experience/knowledge:

• Bachelor/Master degree or equivalent in Engineering, Biotechnology, Pharmacy or "Quality Management" applied to industrial process.
• 3-5 years minimum of experience within a GMP environment, biotech/pharmaceutical company.
• Knowledge of FDA, EMA, ICH, Pharmacopoeia regulations, ISO Quality system standards and data integrity principles.
• Knowledge and interest in QC equipment/systems.
• Knowledge in CSV and QC equipment/systems validation.
• Background in QC GMP testing on biopharmaceutical products.
• Fluent in French.
• Oral and written skills in English, fluency is an asset.

Your soft skills:

• Analytical mindset and attention to detail in document reviews.
• Excellent communication skills to effectively collaborate with multidisciplinary teams.
• Solution-oriented approach and ability to manage multiple projects under tight deadlines.

Location: Neuchatel, Switzerland
Sector: Pharmaceutical
Start:
Duration: 12MM+
Ref.Nr.: BH22858

Take the next step and send us your CV and contact phone number on which we can reach you during working hours.
Due to Swiss work permit restrictions, we can only consider applications from Swiss nationals, EU citizens as well as current work-permit holders for Switzerland.
Ukrainian refugees are welcome, we will support you all the way.
By applying, you agree to the storage and processing of your data for the application process. We strictly comply with the applicable data protection laws.