Planning & Scheduling Specialist / Planning & Scheduling Specialistess

Job Title: Specialist, Packaging Compliance Support

The Specialist, Packaging Compliance Support, plays a crucial role in facilitating packaging compliance activities, including batch record preparation and review, investigations, documentation, and training support. This position ensures that packaging support processes are executed in alignment with Standard Operating Procedures (SOPs) and the applicable Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Environmental, Health and Safety (EHS) requirements. The Specialist also promotes compliance-related operational topics and fosters cross-functional collaboration within the assigned area.

Responsibilities:

General Packaging Support

• Investigates Clinical Complaints (CFAIs) within the Packaging Area.
• Conducts investigations related to compliance topics, SAP Quality Notifications, and Corrective and Preventive Actions.
• Manages SOP updates, including attachments and wall documents.
• Performs pre-execution review and preparation of required batch record documents according to SOPs.
• Conducts post-execution review of batch records and supporting documentation according to SOPs.
• Supports training activities, including curriculum updates and training plans.
• Schedules and coordinates tasks and activities within the area of responsibility.
• Acts as a knowledgeable point of contact for assigned work centers.
• Resolves operational issues and addresses SAP-related challenges.
• Participates in cross-functional meetings as necessary.
• Manages archiving activities.
• Supports packaging execution.

Compliance & Safety

• Adheres to dress code and GMP area access requirements.
• Follows proper gowning procedures and personal protective equipment guidelines.
• Supports GMP compliance activities within the area of responsibility.
• Identifies factors that could lead to unblinding.
• Completes all required training before performing assigned tasks.
• Utilizes the facility's environmental monitoring system where applicable.
• Identifies and reports safety issues.
• Supports GDP corrections on behalf of the Head of Packaging Operations, as assigned.
• Reviews monthly nRFT submissions and responds as needed.

Training & Onboarding

• Supports the delivery of training activities and onboarding tasks.
• Facilitates the onboarding and training of new employees according to established curricula and guidelines.
• Ensures personnel are adequately trained for assigned responsibilities.
• Maintains SAP Comet user roles for new hires and role changes.

Your Profile:

• Completed Bachelor’s or Master’s Degree, with relevant experience in pharmaceutical packaging, compliance support, or manufacturing, preferably in a life sciences-related field.
• Experience in pharmaceutical manufacturing, packaging support, compliance support, or a comparable GMP-regulated environment.
• Advanced understanding of GMP, GDP, and EHS requirements relevant to packaging operations.
• Experience with batch record review, documentation processes, investigations, and archiving activities is preferred.
• Proficient in SAP and Microsoft Office applications such as Word and Excel.
• Ability to coordinate tasks, support training activities, and provide day-to-day support for assigned topics.
• Strong attention to detail and ability to work independently within procedural and compliance requirements.
• Excellent collaboration and communication skills for effective interaction across functions and operational teams.
• A team player with a collaborative mindset.
• English language proficiency at C1 level (or above preferred).

The Company

Our Company is a leading biopharmaceutical organization employing over 1,000 individuals across three sites in Switzerland. The headquarters are located in Lucerne, while our Zurich site operates as a global innovation and development hub. We manufacture medicines for clinical trials worldwide and run a forensic laboratory in Schachen (Canton Lucerne). Annually, we conduct approximately 40 clinical trials in Switzerland, primarily focusing on oncology, infectious diseases, and cardiovascular conditions. Our diverse portfolio also includes vaccines for a broad spectrum of diseases affecting children, adolescents, and adults, positioning us as a leader in veterinary medicine as well.

We are committed to our responsibilities towards the local community and actively participate in initiatives such as the “Trendtage Gesundheit Luzern” and the “Alliance Health Competence.” Our dedication to fostering a supportive workplace has earned us recognition as a “Top Employer Switzerland” and “Top Employer Europe.”

The Werthenstein BioPharma site in Schachen is where we engage in innovative research, develop and analyze new biological agents, and supply clinical trial products for global studies. Our facility also hosts a global forensic laboratory dedicated to monitoring our products throughout the supply chain, ensuring the utmost security and safety for our patients.

Apply online using the form below. Please note that only applications matching the job profile will be considered.