Octapharma

Legal Assistant

• Provide substantive support to the Legal Department as well as to other departments on various legal and IP matters
• General administrative support in legal, data protection, and IP matters
• Drafting and revising legal documents
• IP (Intellectual Property) – handling matters related to the patent and trademark portfolio
• Monitoring the company-wide contract lifecycle management (LCM) system for all documents and correspondence related to intellectual property

Legal Assistant, 60–80%

Engineer

• Plan, execute, and oversee qualification activities, including IQ/OQ for systems and facilities
• Support the Group Technical Unit in global and multi-site engineering projects, expansions, and upgrades
• Develop and maintain qualification standards, templates, protocols, and reporting systems
• Coordinate and support the qualification of production equipment, utilities, automation systems, and infrastructure
• Review qualification documentation, deviation reports, risk assessments, and change controls
• Ensure compliance with internal engineering standards and applicable regulations, including GMP, ISO, FDA, and safety requirements
• Work closely with site engineering, maintenance, production, quality, and project teams
• Support troubleshooting and root cause investigations related to technical systems or failed qualifications
• Drive harmonization of qualification practices across multiple company locations
• Provide technical guidance and training to local engineering teams
• Identify opportunities to improve qualification efficiency and asset reliability

Group Lead Qualification Engineer

Full-stack Engineer

• Ensure GxP compliance and validated state of production IT applications across projects and operations, including documentation (URS, risk analyses, IQ/OQ, SOPs) and inspection support
• Design, implement and optimize solutions by analysing business requirements and collaborating with stakeholders as solution architect
• Lead and support IT/OT projects, including vendor coordination, SLA management, and cost/resource planning
• Manage application lifecycle (changes, updates, system ownership incl. backup & recovery) and maintain oversight of the application landscape
• Ensure stable operations through troubleshooting, ticket handling, escalation management and on-call duty
• Act as system admin for production IT systems (e.g. Track & Trace), including user training and knowledge documentation

Group Senior Engineer – Production Applications

Supply Chain

• Rotate through different areas to gain experience and understanding of Octapharma Clinical R&D
• Support the planning and coordination of Investigational Medicinal Product (IMP) distribution to clinical sites and depots in collaboration with Quality, Logistics, and study teams
• Enter, track, and monitor clinical orders and shipments in relevant systems to ensure timely supply
• Assist in managing clinical inventory, including stock levels, expiry dates, and reconciliation activities
• Contribute to the evaluation and documentation of deviations (e.g., temperature excursions) during storage and distribution
• Support forecasting activities by collecting and consolidating demand information and communicating updates to planning teams
• Collaborate with cross-functional teams to set up and maintain clinical supply plans aligned with study requirements
• Assist in preparing and maintaining clinical trial and supply-related documentation in compliance with regulatory requirements (e.g., eTMF, FDA, ICH-GCP)
• Contribute to continuous improvement of supply chain processes and support ongoing clinical projects

Trainee, Clinical Supply Chain – Clinical R&D

QA Engineer

• Act as the Single Point of Contact for supplier quality notifications and change requests across the organization
• Coordinate and ensure impact assessments of supplier quality notifications in collaboration with relevant subject matter experts
• Evaluate supplier changes and ensure appropriate quality and compliance decisions are made
• Develop, maintain and continuously improve procedures and systems related to supplier quality notifications and the notification database
• Support and participate in supplier qualification activities, including audits and quality agreements in the context of supplier changes
• Perform Global Quality Assurance reviews and approvals of specifications following supplier notifications
• Contribute to the development and harmonization of the Pharmaceutical Quality System at Octapharma, including maintaining global procedures and templates

Group Senior Expert, Quality Supplier – Quality Assurance

Auditor

• Ensure quality and regulatory compliance of plasma suppliers at a global level
• Manage change control, deviations, and quality-related contracts
• Conduct external supplier audits and participate in customer and internal audits at our facility
• Analyze and trend supplier-related quality data
• Create, review, and provide training on SOPs and related procedures
• Qualify plasma suppliers and service providers (e.g., testing laboratories, logistics partners)
• Monitor and ensure continuous supplier compliance throughout the lifecycle of supply agreements
• Maintain and annually update plasma supplier data
• Perform data entry and second-level checks in a regulatory database
• Ensure compliance with EU and EMA Plasma Master File (PMF) requirements
• Prepare regulatory documentation for annual PMF submissions; evaluate epidemiological data, trends, and risks
• Prepare regulatory responses for marketing authorizations and PMF approvals
• Collaborate with internal and external stakeholders, including suppliers, health authorities, and cross-functional teams

Quality Auditor – Regulatory Compliance Specialist

• Design and develop endpoint-related solutions and device management platforms
• Review and oversee the team’s demand intake from the business via project tools and ticketing systems
• Participate in the design and development of features and systems, from initial architecture through implementation and post-deployment support
• Collaborate with other platform teams to ensure successful deployment of required deliverables
• Troubleshoot and provide Tier 3 support to resolve complex technical issues related to endpoint systems and infrastructure