Quality Assurance Specialist for Process Validation
2 settimane fa
Key Responsibilities:
- Evaluate manufacturing process documents and equipment cleaning procedures to ensure compliance with validation requirements.
- Develop and implement validation protocols for product manufacturing and aseptic filling, ensuring adherence to regulatory and quality standards.
- Perform thorough cleaning validation of cleaning procedures and ensure periodic cleaning verification to maintain a high level of cleanliness.
- Manage and coordinate validation protocols for cleaning, process, and Media Fill, ensuring seamless execution and documentation.
- Collaborate with cross-functional teams to define protocol contents and actions to be carried out, fostering a culture of quality and collaboration.
- Validate manufacturing processes, cleaning procedures, and APS/Media Fill, ensuring accuracy and precision.
- Support the development and approval of documents for new product transfer and validation, ensuring regulatory compliance.
- Handle deviations related to validation activities, implementing corrective actions to maintain quality standards.
- Ensure accurate execution of validation activities and detailed analysis of results, providing actionable insights for process improvements.
- Draft validation reports and ensure proper archiving of all documentation, maintaining a comprehensive record of validation activities.
- Provide quality support for new product transfer and process qualification, ensuring seamless integration into our quality management system.
Requirements:
- Bachelor's Degree or equivalent in a scientific/pharmaceutical area.
- 2 years of previous related experience in the pharmaceutical sector.
- Knowledge of pharmaceutical techniques, production, and aseptic filling processes.
- Experience in risk management and client service/project management.
- Proficiency in Microsoft Office software.
- Fluent in English with advanced written and oral communication skills.
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