Quality Assurance Manager providing expertise in test planning and automation for a major client in Belgium. Collaborating with cross - functional teams to enhance software quality in an agile environment.
About the role
- Quality Engineer ensuring compliance with regulations and standards in pharmaceutical quality systems. Collaborating on investigations to address nonconformance and supporting rebranding efforts.
Responsibilities
- Leading and supporting investigations and projects to address root causes of nonconformances
- Participating in rebranding activities at the plant
- Ensuring compliance with applicable standards and regulations
- Being a critical team member in service execution
- Working with supplier quality and vendors to ensure conforming input material is delivered to the manufacturing lines
Requirements
- Bachelor’s or Master’s degree in Pharmacy, Biotechnology, Chemistry, Quality Management, or a related scientific field
- Preferred 2–3 years of experience in Quality Assurance / Quality Systems within the pharmaceutical or medical device industry
- Strong knowledge ISO 13485 /EU MDR/ FDA
- Experience working with Quality Management Systems (Deviation Management, CAPA, Change Control, Document Control, Audits, Training)
- Experience with risk management tools (e.g., FMEA)
- Knowledge of validation, qualification, and data integrity principles
- Experience in supporting regulatory inspections and customer quality audits
- Knowledge of GMP
- Ability to lead small quality improvement projects
- Excellent analytical thinking, problem-solving abilities, and attention to detail
- Strong communication skills and ability to collaborate with cross-functional teams (QA, QC, Production, Engineering, Validation)
- Fluent English (written and spoken)
- Experience in using the SAP system is welcome
- Current, valid Driver’s License would be beneficial
Benefits
- Health insurance
- Retirement plans
- Paid time off
- Flexible work arrangements
- Professional development
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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