GMP Compliance Manager m/f/d, Basel-StadtWe are looking for a committed and motivated personality who will actively develop and consolidate the GxP compliance culture in the team and in material management.
As part of the dynamic team, GMP Compliance Managers acts at the central interface between various production and support areas. You are the first point of contact for all compliance issues and play a key role in making the supply of materials smooth and innovative. Working closely with cross-functional colleagues gives us the opportunity to significantly shape and improve GxP compliance processes.
Location: Basel
Contract start: ASAP
End date: August 2026/possible extension
Responsibilities: - Maintain and deepen GxP compliance culture within Materials Supply Chapter and Materials Management
- Sensitization, coaching and support of SMEs for the topics of GxP compliance and process improvement
- Tracking and expansion of compliance-relevant KPIs and annual targets at MM LT level for compliance
- Processing and support in deviations and carrying out root cause analyses as well as implementing the necessary corrective or preventive measures
- Processing and supporting changes as well as implementing the necessary measures
- Planning, processing and implementation of technical changes within Materials Management
- Planning, processing and implementation of project work in the GMP environment
- Preparation, participation and representation of the department in internal and external audits and inspections
- Recreation, revision and review of GMP documents
- Creation and revision of risk analyses as well as contact person for the area of Materials Management for QRM topics
- New creation and optimization of training courses as well as implementation of training courses in the field of materials management
- GMP-compliant design of new workflows and support of existing ones
- Deviation, CAPA and change management (deviation/UPE and PE management)
- Representation of the department during internal and external inspections
Requirements: - Degree in life science or engineering and/or training with extensive practical experience in the field of technical processes in the pharmaceutical industry
- Fluent German and English
- At least 3 years of professional experience in the cGMP environment, especially in managing the implementation of cGMP requirements
- Professional experience in the field of Quality Assurance or Quality Control
- First professional experience in the handling and operation of automated systems in chemical or biotechnological development and production
- In-depth knowledge of the process in your own area of responsibility
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