FUENTE DEL FRESNO TRCHoyOfrecemos:Leon, SpainFull timeJRLife changing therapies.
Integral impact.
Bridge to thousands of biopharma companies and their patients.
We are PCI.
Our investment is in People who make an impact, drive progress and create a better tomorrow.
Our strategy includes building teams across our global network to pioneer and shape the future of PCI.
Main responsibilities To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
The essential duties and responsibilities include the following, but other duties may be assigned.
Document Management and Control - Organize, scan, archive, and maintain R&D; department documentation.
Ensure document traceability, version control, template management, and compliance with internal procedures and GMP requirements.
Documentation Issuance - Generate and issue forms, templates, labels, logbooks, and documentation associated with R&D; trials, equipment runs, engineering batches, manufacturability studies, and pre-stability studies.
Data Management and Reporting - Create, maintain, and update departmental databases and tracking tools using Smartsheet, Excel, and other systems.
Compile data generated during trials and batches and prepare process charts, reports, and graphical trend analyses.
Change Control Support - Coordinate and manage basic document-related change controls and support documentation updates in collaboration with project team members.
Protocol and Report Preparation - Prepare simple protocols, reports, and controlled documents using approved templates and departmental standards.




Production Data Collection and Analysis - Obtain and compile primary data from manufacturing equipment in accordance with cGMP requirements and internal PCI procedures.
Generate process monitoring charts and supporting documentation.
Training Administration - Monitor training compliance within the R&D; department and support the creation, maintenance, and filing of training records.
Personnel Administration - Support onboarding and offboarding activities for R&D; personnel and maintain associated administrative records.
Procurement and Shipment Coordination - Manage purchasing requests, monitor purchase orders, coordinate receipt of materials and samples, and organize R&D; shipments, including samples and development materials.
Continuous Improvement - Identify opportunities to improve documentation workflows, administrative processes, and departmental practices to enhance efficiency and compliance.
Compliance - Maintain knowledge of and comply with all company policies, internal procedures, quality standards, safety requirements, and applicable cGMP regulations.
Work Experience and Skills Required Essential Knowledge of current Good Manufacturing Practices (cGMP), documentation management principles, data integrity requirements, and pharmaceutical development processes.Demonstrated ability to manage multiple administrative tasks simultaneously while maintaining a high level of accuracy and attention to detail.Strong organizational, communication,



and interpersonal skills with the ability to interact effectively across multiple departments.COMMUNICATIONS & CONTACTS: Works directly with R&D; management, scientists, technicians, and project teams.Works closely with Quality Assurance, Quality Control, Supply Chain, Operations, Human Resources, Purchasing, and Project Management departments.Coordinates with internal stakeholders regarding documentation, training, materials, procurement activities, and change controlsAbility to work independently and collaboratively within a multidisciplinary pharmaceutical development environment.Qualifications: Essential Associate Degree, Vocational Training, or Bachelor's DegreeExperience with Microsoft Office applications (Word, Excel, PowerPoint, Teams, Outlook, SharePoint) and database management tools such as Smartsheet.Honesty, integrity, respect and courtesy with all colleagues.Familiarity with cGMP documentation practices and document control systems is highly desirable.Creative with the ability to work with minimal supervision and balance with independent thinking.Resilient through operational and organizational change.Ability to work in a dynamic, fast-paced work environment.Join us and be part of building the bridge between life changing therapies and patients.
Let's talk futureLet ?s shape the future together
Se ofrece:Programmer (SAS & R) with German - Spain-based (remote/hybrid) Madrid, SpainMadrid, SpainFull timeRWe are looking for a highly motivated HTA Programmer (Analyst/Consultant) to support health technology assessment (AMNOG) and market access activities in Germany.
The role is ideally suited for biostatisticians or data scientists with a strong interest in applying clinical evidence t

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