QA Analytics Expert – GMP Compliance for Drug Product

Lonza; Basel; Vor Ort; Vertraulich; Vollzeit

Benefits dieser Stelle

An agile career and a dynamic work cU

An inclusive and ethical workplace

Compensation programs that recognize高成

Zusammenfassung

Lonza's Basel site is offering a fix-term contract as QA Expert Analytics DP within Drug Product Services (DPS). Based in Basel and Stein, Switzerland, the role focuses on QA support for GMP-compliant analytical testing laboratories, including physicochemical and bioassay testing.

You will review and approve deviations, OOS investigations, CAPAs, Change Controls, and GMP documents, while supporting audits and inspections. Strong knowledge of GMP and English is required.

Qualifikationen

• 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.

Aufgaben

• 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.
• 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.

Kenntnisse

GMP knowledge

Quality systems

Analytical laboratory operations

Communication

Stakeholder management

English proficiency

Ausbildung

University degree in Pharmacy, Chemistry, Biotechnology, Life Sciences, or a related scientific discipline

Tools

LIMS

DMS

Trackwise

Jobbeschreibung

Lonza's Basel site is offering a fix-term contract as QA Expert Analytics DP within Drug Product Services (DPS). Based in Basel and Stein, Switzerland, the role focuses on QA support for GMP-compliant analytical testing laboratories, including physicochemical and bioassay testing.

You will review and approve deviations, OOS investigations, CAPAs, Change Controls, and GMP documents, while supporting audits and inspections. Strong knowledge of GMP and English is required.