Biologics Quality Assurance Specialist
hace 7 días
We are seeking a highly skilled Quality Assurance Specialist to oversee and execute product release activities in compliance with regulatory requirements and global standards.
The ideal candidate will have expertise in QA functions, including release activities, sterile production, documentation, data integrity, and regulatory compliance.
This role will cover Sterile Manufacturing Operations and collaborate with expertise in QA functions to ensure the accuracy, completeness, and reliability of quality data.
The Quality Assurance Specialist will be responsible for:
- Overseeing and executing product release activities in compliance with regulatory requirements and company standards
- Providing QA oversight for sterile manufacturing operations, including aseptic processing, sterilization processes, and environmental monitoring
- Managing and reviewing quality documentation, including batch records, standard operating procedures (SOPs), validation protocols, and reports
- Implementing and maintaining data integrity controls to ensure the accuracy, completeness, and reliability of quality data
- Staying abreast of regulatory requirements and industry best practices related to quality assurance
- Contributing to the development, implementation, and maintenance of robust quality systems, including deviation management, change control, CAPA, and risk management processes
The successful candidate will have a strong background in quality assurance and regulatory compliance, with excellent communication and collaboration skills.
At Galderma, we are committed to empowering our employees and promoting their personal growth while ensuring business needs are met.
We are an equal opportunities employer and welcome applications from diverse candidates.
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