Quality Assurance Engineer ensuring compliance across ground segment systems at CROWDCONSULTANTS. Monitoring QA activities and supporting engineering lifecycle in highly regulated space environment.
About the role
- Quality Assurance Analyst ensuring product release quality and compliance in radio pharmaceuticals while contributing to medical innovations.
Responsibilities
- Review production orders and release products to the market (Designated Person).
- Handle quality deviations and manage the change control process.
- Perform validations of manufacturing processes, cleaning, computerized systems, aseptic processing, and sterile filtration.
- Conduct qualifications of equipment, utilities, and infrastructure.
- Conduct internal audits and participate in the market complaint handling process (SAC - Customer Service).
- Manage records of disposals, waste monitoring, and pest control.
- Control quality system documentation and production order reports.
- Manage risks across the production and commercialization chain for sterile products (radiopharmaceuticals).
- Oversee maintenance performed by third-party companies and supplier qualification.
Requirements
- Bachelor's degree in Pharmacy, Chemical Engineering, Production Engineering, and/or Process Engineering.
- Advanced/Fluent English.
- Strong Excel skills.
- Knowledge of Minitab is desirable.
Benefits
- Food allowance
- Meal voucher
- Health insurance
- Dental insurance
- Hybrid work model
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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