QA Expert Analytics

QA Expert Analytics

Lonza

Basel, Switzerland

What you will do:

• Provide QA support to QC functions (clinical and commercial) for GMP compliance-related activities within analytical testing laboratories, including physicochemical and bioassay testing.
• Ensure implementation and adherence to Corporate GMP Quality Manuals and applicable quality standards across Drug Product testing sites.
• Review and approve documentation related to:
  • Analytical method validation.
  • Specifications.
  • Release testing.
  • Stability studies.
• Perform review and approval activities in electronic systems such as LIMS, iLab, DMS, and other GMP-relevant platforms.
• Review and approve Change Controls, Deviations, OOS investigations, and CAPAs related to products, processes, and analytical activities.
• Author, review, and approve GMP documents, including SOPs, procedures, gap assessments, and compliance-related tools.
• Support analytical release activities and technical release of drug product batches.
• Participate in and support customer audits, and health authority inspections.
• Promote and enforce compliance with internal policies and external regulations, including GMP requirements, quality standards, and HSE regulations.
• Collaborate with cross-functional stakeholders to drive continuous improvement and maintain a strong quality culture.

What we are looking for:

• University degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, or a related scientific discipline.
• Several years of experience within a GMP-regulated pharmaceutical or biotechnology environment. Proven experience in Quality Assurance supporting Quality Control laboratories and analytical testing activities.
• Strong knowledge of GMP regulations, quality systems, and analytical laboratory operations. Familiarity with electronic quality and laboratory systems such as LIMS, DMS, Trackwise or equivalent.
• Experience managing and reviewing Deviations, OOS investigations, CAPAs, and Change Controls.
• Good communication and stakeholder management skills within a matrix environment.
• Excellent knowledge of written and spoken English.