Compliance Manager Infrastruktur (w/m/d), 100% — Bachem AG
Role overview
In order to drive our continued organic growth, we are constantly looking for highly qualified specialists.
To strengthen our team in the BBU Engineering Infrastructure department, a committed personality as Compliance Manager (f/m/d), 100% with a focus on infrastructure, utility and engineering compliance in a GMP regulated environment.
• Your tasks: Compliance & Governance Ensuring and further developing regulatory compliance in the area of responsibility for infrastructure and utilities (including GMP, Annex 1, ICH, internal regulations) Maintaining and further developing the compliance framework including guidelines, standards and SOPs Supporting the interpretation of regulatory requirements and their transfer into technical and operational processes Audits, inspections & quality Preparation, support and follow-up of internal and external audits as well as authority inspections Coordination and follow-up of CAPAs, deviations and findings in the assigned area of responsibility Ensuring audit and inspection-ready documentation Change & risk management Evaluating changes (change control) with regard to regulatory and GMP-relevant effects Carrying out and moderating risk analyzes (e.g.
Key requirements
- Bachelor's degree in Law, Politics, or Economics
- At least 5 years of experience in a compliance role
- In-depth knowledge of GMP regulations and international guidelines
- Analytical and communication skills
- Experience working in a regulated environment
- Knowledge of risk management processes
- Ability to work in a team and collaborate with colleagues
- Knowledge of document management software
