The Sterility Assurance Expert will lead assessments, manage contamination control strategies, and oversee aseptic process validation in the pharmaceutical industry, while authoring related documentation and managing multiple projects effectively.

The Qualified Person (QP) certifies medicinal products, ensures compliance with regulatory requirements, provides quality guidance for projects, oversees quality management systems, and supports audits and investigations. They also maintain knowledge of pharmaceutical legislation and assist in continuous improvement initiatives.

The CQV Engineer oversees the development of documentation for Commissioning, Qualifications, and Validation of pharmaceutical facilities. Responsibilities include protocol writing, field verification, report generation, and managing the documentation lifecycle. The role requires expertise in GMP and life sciences, problem-solving skills, and the ability to work independently while leading project teams.

The Senior CSV Engineer is responsible for validating and qualifying computer systems, managing change controls, and ensuring compliance with regulatory requirements. This role involves preparing validation documentation, troubleshooting issues, and communicating within and outside the organization regarding validation policies. The engineer will participate in audits and manage projects using tools like Microsoft Project.

The CQV Engineer develops and manages documentation for commissioning, qualification, and validation of pharmaceutical facilities. Responsibilities include protocol writing, execution, field verification, and generating summary reports, while ensuring compliance in FDA regulated environments.

The Project (CQV) Engineer role involves conducting Commissioning, Qualification, and Validation activities in the life sciences sector, focusing on safety and project timelines. Responsibilities include generating C&Q procedures, writing and reviewing qualification documents, coordinating project resources, and conducting design reviews and equipment testing.

The Project Manager at CAI will lead cGMP integration and delivery of CQV services for Life Sciences clients, managing mid to large projects related to clean utilities and process equipment. Responsibilities include writing and approving CQV documents, managing projects, tracking progress, and coordinating activities during execution.

The Project Manager will lead and coordinate CQV projects, oversee equipment qualification activities, and develop project plans and budgets. They will manage client communication, documentation, and project risks while supporting continuous improvement and ensuring compliance with industry standards.

The Quality Assurance and Validation Engineer will enhance operational quality, ensure compliance with cGMP and regulatory standards, and oversee batch disposition and documentation processes. They will work collaboratively to meet client requirements and drive continuous improvement in quality systems while ensuring safety and quality practices are upheld.

The Salesforce Data Integrity Specialist ensures data accuracy and quality within Salesforce. Responsibilities include implementing data quality standards, conducting audits, managing user permissions, customizing Salesforce features, providing training to users, and improving data management processes.

The Process Engineer will design and specify cGMP process equipment, manage small-to-medium scale projects, support QA Validation, revise process diagrams, investigate equipment issues, and implement improvements. This role emphasizes compliance, safety, and readiness for tech transfer activities.

The Proposal Coordinator at CAI will collaborate with business development and operations teams to develop proposal responses, manage proposal schedules, conduct market research, and ensure timely delivery of proposals. This role emphasizes effective communication, organizational skills, and attention to detail under tight deadlines.

As a Quality Specialist at CAI, you'll ensure compliance with quality systems and regulatory requirements while supporting commercial manufacturing. You'll oversee batch record reviews and certification processes, addressing client needs and improving quality systems. Collaboration and adherence to safety and quality standards are key aspects of the role.

Stiamo cercando un Junior CSV Engineer con 1-3 anni di esperienza e almeno un anno in GMP.

The CQV Engineer will develop documentation for commissioning, qualification, and validation in pharmaceutical facilities. Responsibilities include protocol writing and execution, field verification, and report development, while providing cGMP guidance and support for life sciences clients.

The Senior CQV Engineer at CAI will develop documentation for the commissioning, qualification, and validation of pharmaceutical facilities and equipment, including protocol writing and execution. The role involves managing documentation and directing teams, ensuring compliance with FDA regulations while working with life sciences clients.

The CSV Engineer will develop and execute validation protocols, manage compliance tasks, analyze testing results, and participate in regulatory audits while ensuring computer system compliance in a GMP environment.

The CQV Senior Project Manager leads life sciences clients in CQV project execution and capital project Operational Readiness. Responsibilities include project planning, execution, risk analysis, stakeholder engagement, and communication management over the project lifecycle.

The CQV Engineer is responsible for developing documentation for Commissioning, Qualification, and Validation of pharmaceutical facilities, performing protocol writing and execution, field verification, and developing summary reports at client sites, emphasizing cGMP compliance and project documentation management.

The CSV Engineer will develop and execute protocols and test scripts, identify gaps, and consult on resolutions. Responsibilities include writing documentation related to GxP computer validation and compliance with 21 CFR Part 11 regulations.