Overview
Senior Quality Engineer Jobs in Basel, Switzerland at GXP CONSULTING Switzerland
Title: Senior Quality Engineer
Company: GXP CONSULTING Switzerland
Location: Basel, Switzerland
Did you ever want to work for a company placing human at the heart of its DNA? Are you ready to make a difference? Do you feel excited about the opportunity to collaborate and share your expertise with our industry leaders? YES? SO DO WE!
GXP CONSULTING Switzerland is a Swiss company with a passionate team of Life Sciences professionals. Since 2014 we deliver outstanding industry’s expertise and support to our clients in the complete range of product life cycle.
Senior Quality Engineer (m/f/d)
To support our client and ensure consistently high levels of quality and compliance, we are looking for an experienced Senior Quality Engineer. In this role, you will take on a key responsibility for qualification, validation, and quality assurance activities within a cGMP-regulated environment and actively contribute to the continuous improvement of processes, systems, and teams.
Key Responsibilities:
- Take responsibility for the planning, coordination, and execution of qualification and validation activities for equipment, systems, utilities, cleanrooms, and cleaning processes across the entire lifecycle
- Ensure the ongoing GMP-compliant status of existing systems, including planning and oversight of re-qualification and re-validation activities
- Prepare, review, approve, and execute qualification and validation documentation such as DQ, IQ, OQ, PQ, as well as overarching validation strategies
- Participate in change control, deviation, and CAPA processes related to qualification and validation activities
- Analyze existing processes, identify optimization opportunities, and actively support the implementation of improvement measures
- Support the preparation, execution, and follow-up of regulatory inspections (e.g., FDA, EMA) as well as internal and external audits
- Prepare, review, and maintain additional GMP-relevant documentation (e.g., SOPs, risk assessments, logbooks)
- Actively contribute to cross-functional and project teams, serving as a key interface between Engineering, Manufacturing, QA, and external partners
- Provide technical guidance and mentoring to junior colleagues in validation and quality system activities
- Ensure proper documentation within electronic quality management systems (e.g., SAP, MasterControl, or comparable systems)
- Actively promote a strong quality, safety, and compliance culture across operations
Qualifications:
- Bachelor’s or Master’s degree in engineering, chemistry, pharmacy, process engineering, or a comparable scientific or technical discipline
- At least 5 years of professional experience in a cGMP-regulated environment (pharmaceutical, biotech, or medical device industries)
- Several years of hands-on experience in Quality Assurance, with a strong focus on commissioning, qualification, and validation
- Very good knowledge of GMP requirements and international regulatory standards (Switzerland, EU, USA; FDA, EU GMP, ICH)
- Specific experience in cleaning validation and/or Computer System Validation (CSV) is a strong advantage
- Experience in managing deviations, root cause analysis, and continuous improvement initiatives
- Structured, reliable, and precise working style with a high level of autonomy and accountability
- Solution-oriented, resilient, and communicative personality with a strong quality and customer-focused mindset
- Fluent in German and English, both written and spoken (German required; English at C1 level or higher)
