Bern, Berne, Switzerland
Experienced pharmaceutical QA professional with 10+ years in GMP-regulated environments, combining strong expertise in operational quality, quality management systems and data integrity. Trusted QA business partner in cross-functional teams. Recognized for pragmatic problem-solving, strong stakeholder engagement, and driving compliant and efficient QA processes in dynamic environments.
· Provide QA oversight for stability studies in a GMP-regulated environment · Review and approve quality-relevant documents (protocols, reports) · Act as quality representative in cross-functional project teams (e.g. process changes, PPQ, risk assessments) · Ensure compliant execution of method transfers across internal and CMO projects · Support deviation management and CAPA implementation within projects
· Directed CSL’s global data integrity strategy as process owner, fostering a strong compliance culture within a global matrix organization · Established and implemented global standards for data integrity and audit trail review · Supported inspections and audits with focus on data integrity compliance · Collaborated with QA, QC, IT, and manufacturing teams in a matrix structure · Designed and delivered GMP training programs across a global organization (e-learnings, classroom sessions, internal campaigns)
· Led site-wide data integrity program, including gap analysis and remediation planning · Authored and approved SOPs and standards for data integrity · Conducted internal GMP audits across multiple departments · Supported inspection readiness and compliance activities
· Released drug products to market as deputy FvP/QP · Performed and coordinated over 20 GMP audits (API suppliers and service providers) · Managed deviations, OOS investigations and CAPA implementation · Reviewed and approved GMP documentation including batch records, analytical reports and SOPs · Supported inspections and customer audits · Oversaw environmental, water, and pest control monitoring programs
· Released products in compliance with GMP standards · Managed deviations, OOS investigations, changes and CAPAs · Reviewed batch documentation and analytical data · Acted as QA point of contact for customers · Supported inspections and customer audits
· Managed planning and evaluation of API stability studies · Reviewed analytical data and stability reports · Led environmental monitoring program, ensuring timely execution and data evaluation · Released raw and packaging materials in compliance with GMP standards · Managed planning, execution, and evaluation of mapping and monitoring activities
· Modification of DNA Nanostructures