ProPharma
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The Principal Consultant will lead the development and implementation of analytical strategies for a biotech company's BLA submission process. Responsibilities include creating analytical documentation, evaluating data, and providing subject matter expert support related to analytical development.
The role involves implementing policies and procedures for corporate audits and internal inspections, finalizing documents across various development stages, and covering quality management systems including manufacturing, lab, and packaging.
The Central Study Coordinator is responsible for clinical monitoring of studies and investigational sites, ensuring compliance with protocols, standard operating procedures, and regulatory requirements. Responsibilities include managing technology and research platforms and collaborating with the study team.
The Freelance/Contract Qualified Person will support a pharmaceutical brand by performing batch release activities, reviewing SOPs, assisting in QMS setup, and ensuring compliance with regulations. This role requires proven experience with solid dosage products, strong stakeholder skills, and fluency in German and English.
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.
As a GCP Auditor, you will be responsible for assessing compliance and quality in various biotech, medical device, and pharmaceutical organizations. The role involves evaluating clinical trials, ensuring adherence to regulations, and contributing to the creation of safe and effective therapies.
The Buyer will oversee purchasing activities in the Life Sciences/Biopharmaceuticals industry, managing the procurement cycle, analyzing data for buying practices, and utilizing ERP systems for purchase order lifecycle in a contract position.
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 Compliance Consultant will assist in revising and reviewing approximately 3000-5000 documents, supporting document control efforts, and providing training as necessary. The role requires experience in quality and compliance, with a preference for familiarity with TrackWise Digital and GCP/GMP standards. The consultant will work full-time for 6 months in a hybrid environment with limited onsite presence.
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 Technical Writer will develop and maintain documentation for pharmaceutical and biotech processes, requiring a quick learning curve and proactivity to meet deadlines. Strong technical writing skills and knowledge of data criticality in a high-volume environment are essential.