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About the role
Key responsibilities & impact- Provide proactive quality presence on the shopfloor to ensure uninterrupted, compliant manufacturing operations and meeting adherence to schedule
- Act as the primary QA point of contact for production teams enabling fast, informed decision-making and real-time issue resolution
- Ensure seamless QA support by coordinating across QA functions to deliver consistent, and efficient quality support to manufacturing and support preparing quality rated answers for customer requests
- Enforce strict adherence to internal procedures and GxP requirements supporting right-first-time execution and minimizing delays
- Support investigations into deviations and non-conformances, ensuring robust root cause analysis, effective CAPA implementation, and timely closure
- Accelerate by facilitating rapid assessments and ensuring high-quality documentation of quality-related matters
- Represent QA in daily and weekly shop floor meetings, addressing quality risks and promoting a solutions-oriented mindset
- Lead and contribute to continuous improvement initiatives that enhance quality performance, reduce waste, and increase operational efficiency
- Foster a culture of ownership and accountability on the shopfloor, where quality, accountability, and continuous improvement is seen as an enabler
Requirements
What you’ll need- University degree (Bachelor/Master) in Chemistry, Organic Chemistry, Natural Sciences, or a comparable scientific or technical discipline, with relevant experience in the field
- Minimum of 5 years of professional experience in API manufacturing, preferably within a CDMO environment
- Demonstrated expertise in quality assurance, with direct exposure to manufacturing operations
- Strong working knowledge of GMP, regulatory requirements, and ALCOA+ principles
- High level of interest in manufacturing processes and operational QA topics, with a mindset geared toward best practices and modern technologies
- Familiarity with quality systems and documentation processes, including deviation handling, CAPA, and change control
- Experience with or willingness to develop skills in Lean, Six Sigma, or other continuous improvement methodologies
- Proficient in both written and spoken German and English.
Benefits
Comp & perks- Flexible working hours with home office days and an option for obtaining additional vacation days through workload reduction
- Employee development through numerous internal and external training opportunities
- 60% coverage of pension fund contributions by Bachem AG as well as option for extra-mandatory pension provision with our Pension Plan Plus
- Access to the Swibeco benefits platform with discounts from external partners
- Fresh, healthy and varied food in our staff restaurant
- A wide range of free sports activities on the Bachem Campus
ATS Keywords
✓ Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
quality assuranceGMPALCOA+ principlesdeviation handlingCAPAchange controlLeanSix Sigmaroot cause analysisdocumentation processes
Soft Skills
proactivedecision-makingissue resolutioncontinuous improvementownershipaccountabilitysolutions-oriented mindsetcommunicationcollaborationorganizational