QC Analytical Project Lead – GMP, Cross-Functional

Bachem SA; Vionnaz; Vor Ort; CHF 120.000 - 180.000; Vollzeit

Zusammenfassung

Bachem SA in Vionnaz, Switzerland, is seeking a QC Analytical Project Manager to coordinate analytical activities across the project lifecycle, ensuring delivery of customer projects with top quality and compliance.

You will lead release testing, stability studies, method development and validation, manage transfers to internal and external partners, and drive GMP adherence and continuous improvement.

Qualifikationen

• Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field.
• Proven experience in project management within a GMP-regulated pharmaceutical environment.
• Strong understanding of analytical methods, method development, validation, and international pharmacopoeias.
• Good knowledge of pharmaceutical regulatory requirements and quality systems.
• Ability to coordinate multiple stakeholders and successfully manage cross-functional projects.
• Strong analytical thinking, problem-solving, communication, and stakeholder management skills.
• Excellent command of MS Office and project management tools; experience with LIMS, CDS, MasterControl, and SAP is an advantage.

Aufgaben

• Act as the primary QC Analytical Operations representative within cross-functional project teams.
• Lead and coordinate analytical activities including release testing, stability studies, API characterization, method development, validation, and specification setting.
• Manage analytical transfers to internal departments, manufacturing sites, and external partners.
• Evaluate complex analytical data, provide scientific recommendations, and communicate results to customers and stakeholders.
• Define and implement analytical and quality control strategies aligned with customer needs and Bachem best practices.
• Monitor project timelines, budgets, resources, quality events, deviations, CAPAs, and change controls.
• Organize and facilitate project meetings while ensuring effective collaboration between internal and external partners.
• Drive continuous improvement initiatives and ensure compliance with GMP, regulatory, quality, and safety requirements.

Kenntnisse

Cross-functional coordination

Analytical thinking

Problem-solving

Stakeholder management

Communication skills

Ausbildung

Analytical Chemistry / Biochemistry / Pharmaceutical Sciences degree

Tools

MS Office

LIMS

CDS

MasterControl

SAP

Jobbeschreibung

Bachem SA in Vionnaz, Switzerland, is seeking a QC Analytical Project Manager to coordinate analytical activities across the project lifecycle, ensuring delivery of customer projects with top quality and compliance.

You will lead release testing, stability studies, method development and validation, manage transfers to internal and external partners, and drive GMP adherence and continuous improvement.