GMP Officer (QC) (7099)

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 is a specialized search and recruitment partner for the Life Sciences industry, serving clients and candidates since 1997. We enable careers by connecting talented professionals with meaningful opportunities, and we support our clients in engaging, retaining, and developing the right talent when needed.

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a:

GMP Officer (QC)

on a 12-month contract, with possibilities of extension. This role is based in Basel, Switzerland, and requires work-onsite 5 days per week.

Main responsibilities:

• Drive compliance and operational excellence within our Quality Control analytical laboratories supporting biopharmaceutical manufacturing.
• Lead end-to-end deviation investigations, root-cause analysis (RCA) and author comprehensive Corrective and Preventive Action (CAPA) plans.
• Write, review and manage Quality Change Requests and associated quality-relevant documentation to meet tight submission timelines.
• Act as a key compliance bridge between Quality Control (QC) analytical teams and central Quality Assurance (QA) stakeholders.
• Partner directly with lab technicians, conducting interviews and gathering analytical data across physico-chemical and bioanalytical workflows.
• Support compliance activities related to sample management processes and analytical instrument qualification protocols.
• Foster continuous process improvement within the QC track systems and mentor lab staff on data integrity standards.

Qualifications and Experience:

• Relevant working/residency permit or Swiss/EU-Citizenship required.
• Educational background with a Bachelor's degree (BSc required; MSc or PhD preferred) in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related discipline.
• Minimum 5 years of practical experience within analytical chemistry, bioanalytics or a GMP laboratory environment.
• Proven expertise in authoring quality-relevant records, managing deviations, OOX investigations and CAPA implementation.
• Strong practical knowledge of GMP principles, analytical methods, data integrity, instrument qualification and sample management.
• Demonstrated hands-on experience performing structured root-cause analysis techniques in a laboratory setting.
• Professional business fluency in English (written and spoken) is required; basic German language skills are an advantage.