GMP QC Lead: Deviation, CAPA & Data Integrity

CTC Resourcing Solutions AG; Basel; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

CTC Resourcing Solutions AG is seeking a GMP Officer (QC) for a 12-month contract based in Basel, Switzerland, working onsite five days per week. The role focuses on driving compliance, corrective actions, and data integrity within QC analytical laboratories supporting biopharmaceutical manufacturing.

Qualifications include a Bachelor’s in a related field and at least 5 years of GMP analytical experience. Fluency in English is required; German is a plus.

Qualifikationen

• Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences or related field (MSc/PhD preferred).
• Minimum 5 years in analytical chemistry, bioanalytics or GMP labs.
• Experience authoring quality-relevant records, deviations, RCA and CAPA.
• Strong GMP knowledge, data integrity, instrument qualification, and sample management.

Aufgaben

• Drive compliance and operational excellence within QC analytical laboratories for biopharmaceutical manufacturing.
• Lead end-to-end deviation investigations, root-cause analysis (RCA) and CAPA plans.
• Write, review and manage Quality Change Requests and related documentation.
• Act as a bridge between QC analytical teams and QA stakeholders.
• Partner with lab technicians to interview staff and gather data across physico-chemical and bioanalytical workflows.
• Support compliance activities related to sample management and instrument qualification.
• Foster continuous process improvement within QC systems and mentor lab staff on data integrity.

Kenntnisse

GMP knowledge

Quality Control

Deviation investigations

CAPA implementation

Data integrity

Instrument qualification

Root-cause analysis

Ausbildung

Bachelor's degree in Chemistry/Biochemistry/Pharmaceutical Sciences or related

Tools

Quality System Documentation

Jobbeschreibung

CTC Resourcing Solutions AG is seeking a GMP Officer (QC) for a 12-month contract based in Basel, Switzerland, working onsite five days per week. The role focuses on driving compliance, corrective actions, and data integrity within QC analytical laboratories supporting biopharmaceutical manufacturing.

Qualifications include a Bachelor’s in a related field and at least 5 years of GMP analytical experience. Fluency in English is required; German is a plus.