Systems Engineer focusing on planning and coordinating systems engineering tasks for HVDC projects in Germany's energy transition. Collaborating with multi - cultural teams to achieve project objectives.
About the role
- Key Quality representative for Contract Manufacturing Organisations at Karo Healthcare. Ensuring compliance with GMP and driving product quality reviews and supplier management.
Responsibilities
- **What you’ll be doing**
- Act as a key Quality representative for Contract Manufacturing Organisations (CMOs), ensuring compliance with GMP, GDP and Directive 2001/83/EC
- Evaluate, qualify, approve and manage suppliers within Karo’s Global Quality Management System
- Lead and participate in Technology Transfer and validation activities from a QA perspective
- Drive Product Quality Review (PQR), deviation, change control and CAPA processes in line with global QMS
- Take ownership of selected Global QA processes and contribute to a project-driven way of working within the function
- Plan, lead and conduct external audits of CMOs as well as internal audits; approve audit reports and follow up actions
- Ensure product compliance both before and after release, including deviation handling and follow-up
- Review and approve GMP documentation from CMOs (e.g. specifications, validation protocols/reports, stability documentation, manufacturing instructions)
- Issue and/or approve regulatory documentation (Module 3) and co-sign QA agreements where applicable
- Build strong, collaborative relationships with suppliers and internal stakeholders across Quality and Operations
Requirements
- **Requirements**
- University degree in a scientific or technical field; Master’s degree in Pharmacy, Medicine, Chemistry or Chemical Engineering is preferred
- At least 2 years of experience within Quality Assurance in the pharmaceutical and/or medical device industry
- Solid knowledge of GMP, GDP and EU pharmaceutical regulations (including Directive 2001/83/EC)
- Experience working with CMOs and outsourced manufacturing environments
- Comfortable in a fast-paced, hands-on setting with multiple stakeholders and priorities
- Structured, detail-oriented and confident in decision-making within a regulated environment
- Fluent in English; additional languages are a plus
Benefits
- Opportunity to create, grow, and encourage
- Apart from a competitive salary pack, there are lots of growth opportunities to meet your personal ambitions
- Flexible schedule and life work balance
- Responsibility for exciting and challenging projects that have a direct, visible impact on our customers and the industry
- Very positive work environment in a young, international, and motivated team
- Start-up spirit while being a part of the large international organization with strong values
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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