QA Systems Manager (m/f/d)

unisite ag; Lavamünd; Vor Ort; EUR 137.000 - 190.000; Vollzeit

Zusammenfassung

Pentapharm AG, a Swiss SME supplying active ingredients for personal care, pharmaceutical and haemostasis diagnostics, seeks a hands-on QA Systems Manager to ensure the operation and continuous compliance of our Quality Management System.

You will own key QA systems including eQMS, training management,Quality Agreements and PQRs, and work with internal and external partners to meet GMP/GDP requirements. Fluency in German and English is required.

Qualifikationen

• MSc or higher in a scientific field related to QA.
• Experience in GMP- or ISO-regulated production environments.
• Strong knowledge of GMP requirements and QMS, eQMS exposure.

Aufgaben

• Administer and maintain the eQMS and electronic training management.
• Coordinate Quality Agreements with customers and suppliers.
• Maintain Site Master File and coordinate Product Quality Reviews.
• Lead investigations of complaints and CAPA activities.
• Support Change Control, quality questionnaires, audits and inspections.
• Ensure data integrity and GMP/GDP compliance.

Kenntnisse

GMP knowledge

Quality Management Systems

eQMS

document management

CAPA

Change Control

training management

audits

IVDR knowledge (advantage)

organizational skills

independence & ownership

cross-functional collaboration

German & English

IT & quality tools

Ausbildung

MSc in Biology, Chemistry, Pharmacy, Quality Management or related scientific field

Jobbeschreibung

unisite ag is a service provider in the field of Employer Branding & Talent Management. We provide consulting services to clients in the chemistry, pharmaceutical, biotech, medical device, and life sciences industries.

Our client, Pentapharm AG, is a Swiss SME with a long-standing tradition as an innovative and reliable supplier of active ingredients for the personal care, pharmaceutical and haemostasis diagnostics industries.

On behalf of our client, we are currently looking for a: QA Systems Manager (m/f/d)

Location: Aesch, BL

PositionFor the Quality Assurance team, we are looking for an experienced and hands‑on QA Systems Manager (m/f/d) to ensure the effective operation and continuous compliance of our Quality Management System.

In this role, you will take ownership of key QA systems and processes, including eQMS and training management, Quality Agreements, complaints and Product Quality Reviews. You will work closely with internal stakeholders and external partners to ensure compliance with applicable GMP/GDP requirements.

1. Administer and maintain the electronic Quality Management System (eQMS) and electronic training management system, including document control, user access, training records and related QA system activities
2. Support onboarding and offboarding activities related to training assignments and eQMS access
3. Coordinate Quality Agreements with customers and suppliers, including preparation, review, approval and periodic updates
4. Coordinate the maintenance and periodic review of the Site Master File
5. Initiate and coordinate annual Product Quality Reviews (PQRs), including cross-functional data collection and follow-up
6. Manage customer complaints and coordinate investigations and related CAPA activities
7. Support Change Control assessments as the Quality representative
8. Prepare and review QA-related sections of customer quality questionnaires
9. Support customer audits and regulatory inspections, including preparation, back-office coordination and follow-up of observations
10. Ensure QA systems and documentation remain compliant with applicable GMP/GDP requirements and data integrity principles

1. MSc in Biology, Chemistry, Pharmacy, Quality Management or a related scientific field
2. 10+ years of professional experience in a GMP- or ISO-regulated production environment
3. Strong knowledge of GMP requirements and Quality Management Systems
4. Practical experience with eQMS and electronic document management systems
5. Sound knowledge of key quality processes, including complaints, CAPA, Change Control, training management and audits
6. Familiarity with pharmaceutical quality standards and regulatory requirements; basic knowledge of IVDR is an advantage
7. Strong organizational skills and a structured, detail-oriented approach to work
8. Ability to work independently, take ownership and collaborate effectively across functions
9. Very good communication skills in German and English
10. Confident user of common IT systems and digital quality tools