Quality Assurance Expert
Share
Job Location:
Neuchâtel - Switzerland
Hourly Salary:
CHF CHF 62 - 62
Posted on:
11 hours ago
Vacancies:
1 Vacancy
Job Summary
Quality Assurance Senior Expert Fill & Finish / Visual Inspection
Location: Site-based - Neuchâtel Switzerland
Department: Quality Operations
Working Pattern: Day shift with 28 shifts during Aseptic Process Simulations (APS)
About the Role We are seeking a Quality Assurance Senior Expert to join our Quality Operations team and support the implementation of a new Fill & Finish and Visual Inspection area within a sterile pharmaceutical manufacturing site.
This position plays a key role in ensuring GMP compliance providing on-the-floor quality oversight and maintaining high standards across documentation deviation management and aseptic operations. The role is primarily site-based with close collaboration across Manufacturing Engineering Sterility Assurance and Quality teams.
Key Responsibilities:
It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference 171589 in all correspondence.
Location: Site-based - Neuchâtel Switzerland
Department: Quality Operations
Working Pattern: Day shift with 28 shifts during Aseptic Process Simulations (APS)
About the Role We are seeking a Quality Assurance Senior Expert to join our Quality Operations team and support the implementation of a new Fill & Finish and Visual Inspection area within a sterile pharmaceutical manufacturing site.
This position plays a key role in ensuring GMP compliance providing on-the-floor quality oversight and maintaining high standards across documentation deviation management and aseptic operations. The role is primarily site-based with close collaboration across Manufacturing Engineering Sterility Assurance and Quality teams.
Key Responsibilities:
- Prepare review and approve GMP controlled documentation
- Review and approve Master Batch Records
- Manage deviations related to production events using quality systems (e.g. TrackWise) including investigations impact assessments and CAPA definition
- Provide QA oversight on the shop floor including approval of aseptic interventions during Aseptic Process Simulations (APS)
- Participate in relevant cross-functional meetings and apply the quality escalation process
- Ensure compliance with training requirements and system access management
- Support routine Quality Oversight activities such as GMP tours and continuous improvement initiatives
- Masters degree (Bac 5) in a scientific or technical discipline
- 23 years of operational cGMP experience in Quality Operations
- Experience in a pharmaceutical manufacturing environment producing sterile injectable products
- Strong understanding of sterile manufacturing processes from upstream activities to aseptic filling
- Solid knowledge of cGMP requirements and Quality Systems (Deviations CAPA Change Control Training Documentation)
- Excellent written and verbal communication skills in French and English
- Proficient with Microsoft Office tools
- Recognized for teamwork autonomy agility and attention to detail
- Minimum 4 days per week on site
- Occasional home office possible for specific tasks upon approval
- Direct reporting to the QA Manager
- High level of daily interaction with Manufacturing Engineering Sterility Assurance Quality Ops and Training teams
It is essential that applicants hold entitlement to work in Switzerland. Please quote job reference 171589 in all correspondence.
Company Industry
Pharmaceuticals
About Company
Idibu
100 employees
Every business is now operating in an environment that’s susceptible to change. idibu has evolved against this changing backdrop. Whether driven by legislation, technology, customer demand or the economy, businesses now need to be agile and fleet of foot to ensure they can attr ... View more
