The posting
The Specialist, Packaging Compliance Support, is responsible for supporting packaging compliance activities across batch record preparation and review, investigations, documentation, training support, and operational coordination. This role helps ensure that packaging support processes are executed in alignment with SOPs and applicable GMP, GDP, and EHS requirements, while supporting compliance-related operational topics and cross-functional collaboration within the assigned area.
Responsibilities:
1. General Packaging Support
- Investigates Clinical Complaints (CFAIs) within 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.
- Serves as a knowledgeable point of contact for assigned work centers.
- Resolves operational issues and addresses SAP-related issues.
- Participates in cross-functional meetings as needed.
- Manages archiving activities.
- Supports packaging execution
2. Compliance & Safety • Adheres to dress code and GMP area access requirements. • Follows proper gowning procedures and personal protective equipment requirements. • Supports GMP compliance activities within the area of responsibility. • Identifies factors that could lead to unblinding. • Completes all required training before performing assigned tasks. • Uses the facility 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 required.
3. Training & Onboarding
- Supports the delivery of training activities and onboarding tasks.
- Supports onboarding and training of new employees according to established curricula and guidelines.
- Helps ensure personnel are trained for assigned responsibilities.
- Supports maintenance of SAP Comet user roles for new hires and role changes.
Your Profile: • Competed Bachelor or Masters 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 preferred. • Working knowledge of 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. • Strong collaboration and communication skills for working across functions and supporting operational teams. • Strong team player with a collaborative mindset. • English language proficiency at C1 level (or above preferred).
THE COMPANY
Our Company is a leading biopharmaceutical company employing over 1,000 people in Switzerland at three sites. The company’s headquarters are in Lucerne. At the site in Zurich, the company operates a global innovation and development hub. In addition, we manufacture medicines for global clinical trials and operate a forensic laboratory in Schachen (Canton Lucerne). We conduct around 40 clinical trials annually in Switzerland. The main therapeutic areas include oncology, infectious diseases, cardiovascular and cardiometabolic diseases. We also have a broad portfolio of vaccines for the prevention of diseases in children, adolescents, and adults and we are one of the leading companies in veterinary medicine. Furthermore, we take our responsibility to the local community seriously and have been involved for many years in initiatives such as the «Trendtage Gesundheit Luzern» and the «Alliance Health Competence».
We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe” showing the company’s commitment to our employees and the community around us.
Our Werthenstein BioPharma site in Schachen is where we conduct cutting-edge research, develop and analyze new biological agents and supply clinical trial products for global clinical studies. The site is also home to one of our global forensic laboratories where we carefully monitor our products through the supply chain to ensure security and safety for our patients.
