QA Systems Lead: GMP eQMS & Compliance

unisite ag; Aesch; Vor Ort; Vertraulich; Vollzeit

Zusammenfassung

unisite ag in Basel-Landschaft, Aesch, is seeking a hands-on QA Systems Manager to own and continuously improve the QA systems landscape, including eQMS, training management, and quality agreements. You will collaborate with internal teams and external partners to ensure GMP/GDP compliance and data integrity.

The role requires a MSc in a relevant field and 10+ years in GMP/ISO environments, with strong German and English communication skills and proven eQMS experience.

Qualifikationen

• 10+ years of professional experience in a GMP- or ISO-regulated environment.
• Strong knowledge of GMP requirements and Quality Management Systems.
• Practical experience with eQMS and electronic document management systems.
• Familiarity with pharmaceutical quality standards and regulatory requirements; IVDR knowledge is a plus.
• Excellent organizational skills and an analytical, detail-oriented approach.
• Ability to work independently and collaborate across functions.
• Very good German and English communication skills.

Aufgaben

• Administer and maintain the eQMS and training management systems, including document control and access management.
• Coordinate Quality Agreements with customers and suppliers, including reviews and updates.
• Coordinate Site Master File maintenance and annual Product Quality Reviews (PQRs).
• Manage customer complaints and drive investigations and CAPA activities.
• Support Change Control assessments as QA representative.
• Prepare QA sections of customer quality questionnaires and support audits/inspections.
• Ensure ongoing GMP/GDP compliance and data integrity across QA systems.

Kenntnisse

GMP knowledge

Quality Management Systems

eQMS experience

Documentation control

Regulatory inspections

Cross-functional collaboration

Ausbildung

MSc in Biology/Chemistry/Pharmacy

Tools

eQMS software

Electronic document management

Quality questionnaires

Jobbeschreibung

unisite ag in Basel-Landschaft, Aesch, is seeking a hands-on QA Systems Manager to own and continuously improve the QA systems landscape, including eQMS, training management, and quality agreements. You will collaborate with internal teams and external partners to ensure GMP/GDP compliance and data integrity.

The role requires a MSc in a relevant field and 10+ years in GMP/ISO environments, with strong German and English communication skills and proven eQMS experience.