Specialist in Planning and Scheduling / Specialistin in Planning and Scheduling

Job Title: Specialist, Packaging Compliance Support

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

Key Responsibilities

• General Packaging Support:
  • Investigate Clinical Complaints (CFAIs) within the Packaging Area.
  • Conduct investigations related to compliance topics, SAP Quality Notifications, and Corrective and Preventive Actions.
  • Manage SOP updates, including attachments and wall documents.
  • Perform pre-execution review and preparation of required batch record documents in accordance with SOPs.
  • Conduct post-execution review of batch records and support documentation as per SOPs.
  • Support training activities, including curriculum updates and training plans.
  • Schedule and coordinate tasks and activities within the area of responsibility.
  • Serve as a knowledgeable point of contact for assigned work centers.
  • Resolve operational and SAP-related issues.
  • Participate in cross-functional meetings as needed.
  • Manage archiving activities.
  • Support packaging execution.
• Compliance & Safety:
  • Adhere to dress code and GMP area access requirements.
  • Follow proper gowning procedures and personal protective equipment requirements.
  • Support GMP compliance activities within the designated area.
  • Identify factors that could lead to unblinding.
  • Complete all required training before performing assigned tasks.
  • Utilize the facility environmental monitoring system where applicable.
  • Identify and report safety issues promptly.
  • Support GDP corrections on behalf of the Head of Packaging Operations, as assigned.
  • Review monthly nRFT submissions and respond as required.
• Training & Onboarding:
  • Assist with the delivery of training activities and onboarding processes.
  • Support the onboarding and training of new employees in alignment with established curricula and guidelines.
  • Ensure personnel are adequately trained for their assigned responsibilities.
  • Maintain SAP Comet user roles for new hires and during role changes.

Your Profile

• 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 similar GMP-regulated environment.
• Advanced understanding of GMP, GDP, and EHS requirements pertinent to packaging operations.
• Experience with batch record review, documentation processes, investigations, and archiving activities is preferred.
• Familiarity with SAP and Microsoft Office applications, including Word and Excel.
• Ability to coordinate tasks, support training activities, and provide daily support on assigned topics.
• Strong attention to detail and capability to work independently under procedural and compliance guidelines.
• Excellent collaboration and communication skills for effective interaction across functions and support for operational teams.
• Team player with a collaborative mindset.
• Proficiency in English at C1 level or above is preferred.

The Company

Our company is a leading biopharmaceutical firm employing over 1,000 people across three sites in Switzerland. The headquarters is located in Lucerne, while our Zurich site serves as a global innovation and development hub. Additionally, we manufacture medicines for worldwide clinical trials and operate a forensic laboratory in Schachen (Canton Lucerne). Each year, we conduct around 40 clinical trials in Switzerland, focusing on therapeutic areas such as oncology, infectious diseases, cardiovascular, and cardiometabolic diseases. Our portfolio also includes a wide array of vaccines designed to prevent diseases in children, adolescents, and adults, making us a significant player in the field of veterinary medicine.

We are deeply committed to our social responsibilities and have participated in various initiatives, such as the “Trendtage Gesundheit Luzern” and the “Alliance Health Competence.” We take pride in being recognized as a “Top Employer Switzerland” and “Top Employer Europe,” reflecting our dedication to our workforce and the communities we serve.

Our Werthenstein BioPharma site in Schachen is equipped for cutting-edge research, development, and analysis of new biological agents, supplying clinical trial products for global studies. This facility is also home to one of our global forensic laboratories, where we meticulously monitor our products throughout the supply chain to ensure security and safety for our patients.

Apply online using the form below. Only applications matching the job profile will be considered.