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GMP Compliance Specialist
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GxP Compliance Specialist – Quality Control
Fenil-sur-Corsier, Switzerland – 6-Month Contract (with the possibility of extension)
Job Description
As a GxP Compliance Specialist – Quality Control, you will join the Global Analytical Development, Analytical Operations & QC organization in Fenil-sur-Corsier, Switzerland.
In this role, you will serve as the QC compliance expert, supporting daily laboratory operations, ensuring adherence to GxP and data integrity standards, and driving continuous improvement across quality systems. You will collaborate closely with QC, QA, and cross-functional stakeholders to maintain inspection readiness, manage deviations, and uphold robust documentation and training frameworks.
Key Responsibilities
Quality & Compliance Support (QC Operations)
- Support QC teams in daily operations as the compliance subject matter expert.
- Manage, investigate, and close deviations, non-conformances, events, and related quality records in collaboration with SMEs.
- Contribute to data reviews ensuring compliance with established quality requirements and GxP expectations.
- Perform periodic reviews and ensure timely progression of deviations, change controls, CAPAs, and investigations.
- Maintain and improve the data integrity knowledge base, including DI risk assessments, action plans, and routine reporting to leadership.
Documentation & Regulatory Alignment
- Author, review, approve, and maintain relevant SOPs, Work Instructions, and quality documentation.
- Contribute to the evaluation of regulatory/pharmacopoeia updates relevant to QC processes.
- Support audit preparation and directly interact with internal auditors and external regulatory agencies.
- Recommend and implement system, process, and procedural improvements within QC compliance activities.
- Training, Cross-Functional Collaboration & Continuous Improvement
- Serve as the key liaison with QA to resolve compliance issues and drive corrective actions.
Essential Skills
- 5–10 years of experience in QC, analytical development, or quality/compliance roles within biotech, pharma, or other regulated GxP environments.
- Strong understanding of GLP/GMP and Quality System requirements (ICH, FDA, EMA).
- Hands-on experience with deviations, CAPAs, change control, and quality documentation.
- Solid investigational and problem-solving skills; ability to interpret complex situations and recommend effective solutions.
- Prior experience supporting audits and interactions with health authorities.
- Knowledge of data generation, data processing, and data quality principles.
- English fluency (B2+ required); French is an advantage.
Preferred Experience
- Practical experience working in a QC laboratory setting.
- Familiarity with laboratory information systems (LIMS), digital QC tools, automation technologies, and lean methodologies.
- Experience driving or supporting data integrity programs.
Additional Insights
- Start Date:
ASAP - Contract Duration:
6 months (with the possibility of extension) - Location:
Fenil-sur-Corsier, Switzerland
Interested?
Send your CV to
Khanyi Mabena
at
k.-
, or contact directly at
to learn more.
