GMP QC Lead: Investigations, CAPAs & Compliance

BioTalent; Basel; Vor Ort; CHF 110.000 - 140.000; Vollzeit

Zusammenfassung

BioTalent Basel is seeking an experienced GMP Officer (QC) to support quality control activities in a pharmaceutical environment. The role focuses on GMP compliance, investigations, deviations, CAPAs and quality documentation, working closely with both QC and QA teams.

You will author deviations and investigations, conduct root-cause analysis, define CAPAs, review GMP records, and contribute to continuous improvement across Quality Assurance and Quality Control.

Qualifikationen

• Minimum 5 years of relevant professional experience.
• Strong background in analytical chemistry and quality control.
• Good knowledge and practical experience of GMP requirements.
• Experience authoring deviations and investigations.
• Experience with change requests/change controls and CAPAs.
• Knowledge of root-cause analysis, OOX and data integrity.
• Business-fluent English; German knowledge is advantageous.

Aufgaben

• Author and manage deviations, investigations and change requests.
• Conduct root-cause analysis for quality-related issues.
• Define and document appropriate CAPAs.
• Review GMP and quality-related records.
• Provide guidance on quality documentation and compliance.
• Support the timely completion and closure of quality records.
• Collaborate closely with Quality Assurance and Quality Control teams.
• Support continuous improvement and other QC quality activities as required.

Kenntnisse

GMP compliance

Root-cause analysis

Quality Control

Investigations

CAPA implementation

Data integrity

Business English

Ausbildung

BSc or higher in Chemistry/Biochemistry/Pharmaceutical Sciences or related field

Jobbeschreibung

BioTalent Basel is seeking an experienced GMP Officer (QC) to support quality control activities in a pharmaceutical environment. The role focuses on GMP compliance, investigations, deviations, CAPAs and quality documentation, working closely with both QC and QA teams.

You will author deviations and investigations, conduct root-cause analysis, define CAPAs, review GMP records, and contribute to continuous improvement across Quality Assurance and Quality Control.