Regulatory Compliance and Quality Assurance
1 week ago
We are seeking a highly skilled Regulatory Compliance and Quality Assurance Specialist to join our Biologics team within Manufacturing Science and Technology. In this role, you will be responsible for ensuring compliance with regulatory requirements and maintaining high-quality standards in our manufacturing processes.
Key Responsibilities:
- Ensure compliance with regulatory requirements, including those related to GMP, GDP, and other relevant regulations.
- Collaborate with cross-functional teams to ensure process validation, including documentation, execution, and review of process validation data.
- Maintain comprehensive records of investigations, findings, actions taken, and recommendations, ensuring compliance with regulatory and quality standards.
- Write technical manufacturing documentation and dossier sections, providing responses to regulatory authorities as needed.
Requirements:
- Bachelor's degree in a relevant scientific or engineering field, such as Chemistry, Biochemistry, Chemical Engineering, or a related discipline.
- Prior manufacturing experience within the biopharmaceutical industry, with a minimum of 6 years of experience in a biopharmaceutical or manufacturing environment.
- Experience in drug substance and/or drug product manufacturing within a GMP environment.
- Previous experience of regulatory audits and compliance.
About Us:
At Galderma, we are committed to delivering high-quality products and services that meet the evolving needs of consumers and patients worldwide. Our portfolio includes a range of innovative dermatological products and services, designed to address various skin-related conditions and improve patient outcomes.
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