Responsible Person
vor 4 Wochen
Job Description:
The Responsible Person at AbbVie ensures that all business is conducted in compliance with Swiss law on Medicinal Products and company policies. This role is responsible for direct technical supervision of the operation, safety, efficacy, and quality of the medicine, and ensures proper handling of pharmaceutical products, importing, and wholesaling in accordance with Good Distribution Practice (GDP) rules.
Key Responsibilities:
- Act as FvP for import and wholesaling in accordance with Swiss law on Medicinal Products and Swissmedic technical interpretation I-SMI.TI.17 Responsible Person requirements V7.
- Supervise business activities and ensure appropriate wholesaling practices.
- Apply and maintain necessary licenses for Immunogen Switzerland GmbH business.
- Ensure Quality Management System availability, implementation, and maintenance for GMP and GDP-related processes.
- Ensure medicinal products are supplied in accordance with GDP rules.
- Partner with stakeholders to gain process understanding and determine best steps forward.
- Ensure manufacturers of imported pharmaceutical products hold valid GMP manufacturing licenses.
- Ensure traceability of purchases and sales of pharmaceutical products and record necessary information.
- Ensure documentation proving quality of traded batches is complete.
- Decide on stop of distribution and recall of batches independently.
- Manage quality and compliance risks.
- Approve all SOPs and controlled documents in conjunction with licensed activities.
- Contact person for and approval of Technical/Quality Agreement related to supply, transportation, and wholesale of medicinal products.
- Quality oversight/auditing of external service providers.
- Manage Health Authority Inspections and Corporate Audits.
- Manage recalls.
- Manage product quality complaints.
- Report quality issues to Swissmedic according to requirements and deadlines.
- Handle quality issues with responsible Supplier/Manufacturing site.
- Stay up-to-date with Swiss regulatory requirements, authority organization, processes, and environment.
- Awareness and implementation of applicable regulations and dissemination to relevant stakeholders.
- Act as contact person for all Quality issues of Immunogen Switzerland GmbH for Swissmedic, Cantonal Health Authority, and Third-Party Manufacturers.
- Plan and perform internal audits.
- Ensure Site Quality Compliance Metrics are reported periodically to Site Management.
- Lead Management Reviews.
- Ensure employees involved in distribution activities perform GDP refresher training at minimum yearly frequency.
- Participate in GMP/GDP-focused course, seminar, congress, or equivalent at minimum once a year.
- Assess education and experience of Deputy FvP and assign delegation.
Qualifications and Experience:
- Degree in Chemistry, Pharmacy, Biology.
- 5+ years' experience in quality assurance, operations, regulatory, or relevant experience. Some supervisory/management experience preferred.
- Knowledge of QA systems and GxP compliance requirements, including regulations and standards affecting device, biologics, and pharmaceutical products.
- Strong influencing, motivational, interpersonal, and relationship building skills at all levels.
- Excellent written and oral communication skills. Very good written and oral German and English.
- Ability to think strategically and enterprise-wide to ensure compliance and business needs are met or exceeded.
- Strong decision-making skills.
- Negotiation skills, effective collaboration, and ability to anticipate needs and requirements.
- Strong computer skills and knowledge of enterprise systems such as SolTraqs, SAP, Attache, and One vault.
- Motivated, communicative, and decisive personality.
- Excel with self-initiative, collaborative skills, organizational talent, and well-structured way of working.
- Holder of responsibility for FvP must have necessary professional training and experience to be accepted by authorities for this function.
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