Search the 8 jobs at ProPharma

The GVP Auditor will lead clinical consulting and auditing projects, executing audits based on regulatory requirements and GCP/GVP guidelines, while promoting customer satisfaction and compliance. Responsibilities include managing the GVP audit program, supporting clients in compliance issues, generating project proposals, and ensuring alignment with quality principles.

The Deviation Support Consultant will provide specialized assistance to clients in New Jersey, focusing on managing deviations in compliance with industry standards. The role involves contributing expertise in regulatory compliance and ensuring alignment with best practices.

The CSV Auditor will oversee the planning and execution of CSV audits, serve as a Subject Matter Expert, and ensure compliance with CSV regulations and internal policies while managing consulting projects and addressing deviations and non-conformances for clients.

The Quality Engineer Support will oversee Quality Assurance for commissioning, qualification, and validation activities in major projects, ensuring compliance with regulatory and quality requirements. Responsibilities include reviewing documentation, escalating critical issues, providing technical consultation, and adhering to cGMP standards.

The Statistical Programmer organizes and produces datasets and tables for clinical trials, coordinates programming among study programmers, accesses and converts data to SAS datasets, oversees vendor programming activities, and reviews data submission packages. Additionally, this role involves mentoring less-experienced programmers and ensuring the accuracy of statistical programming outputs.

The Quality Control Editor reviews and edits clinical documents, regulatory submissions, and publications for accuracy, grammar, and compliance with guidelines. They interpret clinical data as needed and ensure document formatting adheres to templates and style guides. This role requires strong attention to detail and collaboration with the writing team.

The position involves managing Clinical Quality Assurance (CQA) projects, providing consulting, conducting audits, drafting SOPs, and ensuring compliance with GCP, GLP, and GCLP regulations. The role also includes promoting quality programs and addressing regulatory issues for clients.

The CGT/ATMP Senior Consultant will provide expert consultation in quality assurance and regulatory compliance within the cell and gene therapy sector. Responsibilities include auditing, developing Quality Management Systems, providing client training, and ensuring project execution and profitability. The role involves staying updated on regulatory changes and promoting quality services within the industry.