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The QA Manager oversees daily functions of the quality system, ensuring compliance with client specifications and quality standards. Responsibilities include supervising QA staff, managing quality systems, approving deviations and CAPAs, reviewing validation protocols, and providing training and documentation support.

The role of Qualified Person involves certifying manufacturing processes in compliance with UK and EU GMP, reviewing batch documents, conducting audits, and providing guidance on QP requirements. The position also requires maintaining up-to-date knowledge of regulatory requirements and assisting with quality management and inspections.

The Head of Clinical Operations at PCI is responsible for managing logistics, warehousing, clinical supply packaging, and labelling activities at the Großbeeren facility. This role involves ensuring compliance with GMP, SOPs, client-specific requirements, and government regulations, as well as overseeing staff training and development to enhance operational efficiency.

Leading and executing tasks related to day-to-day Quality Assurance (QA) aspects, overseeing Quality Management System (QMS) areas, mentoring QA team members, participating in audits and regulatory activities, and supporting quality-related tasks for strategic projects.

The Category Manager will be responsible for developing and implementing category plans across direct and indirect spend categories, leading cross-functional efforts, cost reductions initiatives, contract negotiation, and supplier management globally for PCI's Development & Manufacturing business segment.

The Quality Auditor is responsible for monitoring and ensuring cGMP compliance, conducting audits on production documentation, and enhancing quality processes on the production floor. Duties include inspecting equipment, verifying sampling, reviewing logs, and participating in continuous improvement initiatives.

The Quality Coordinator prepares documentation for production work orders, reviews batch documentation for compliance with cGMP and customer standards, assists in releasing batches, manages quality metrics, and addresses documentation issues with clients and internal teams.