Responsible Person Germany
vor 3 Monaten
Position**:Responsible (RP) Person Germany**
Reporting into: Sr. Director International Quality & Responsible Person (RP) Switzerland with Dotted Line to GM Germany GmbH
**Position Summary**:
Acting as the Responsible Person (RP) of Apellis, Germany GmbH as required by - 52a AMG.
Legal Basis: - 52a AMG, -- 1a, 4a, 6, 7a, 7b AMHandelsV, - 2.2, 2.3 EU GDP, -19 AMWHV
**Main task (Key Accountabilities)**:
- Authorized to issue instructions to all employees involved in the supply or distribution of the product for Apellis Germany GmbH according to - 2.2 AM-HandelsV, -2.1, 2.2, 2.3 EU GDP
- Implement and maintain a lean, comprehensive, and efficient QMS according to applicable ICH and GxP standards and regulations and taking into consideration the Company’s requirements (e.g., stage, activities ).
- Assume the duties under -19 AMWHV delegated from the Stufenplanbeauftragter / EU QPPV. Notify Stufenplanbeauftragter / EU QPPV when the complaint is associated with the potential Adverse Event or have safety impact.
- Ensure appropriate Product Complaint Handling (Art. 6.2 GDP-LL) and keep oversight of all product complaints of the product in Germany. Keep Stufenplan-beauftragter / EU QPPV informed about the performance of delegated activities.
- Determine need for new SOPs, assist with writing of these, and ensure their revision and GxP compliance.
- Stay abreast of new and revised governmental/industry/company regulations and eensure Apellis QMS and processes meet the requirement.
- Determine GDP related training needs, coordinate/conduct/support trainings, and ensure proper training of SOPs, QMS- and GDP- related aspects.
- Identify issues in quality system processes and improve SOPs accordingly. Encourage improvement in performance and quality_._
- Ensure import and delivery of medicinal product are according to -- 4a and 6 AMHandelsV.
- Deciding on the final disposition of returned, rejected, recalled or falsified medicinal products acc. to - 7b AMHandelsV.
- Approving returns to saleable stock with respect to - 7b AMHandelsV.
- Coordinate product recall activities. Ensure recall related notifications to the authority in case of product quality issues and execute one mock recall annually (-6.5 EU GDP).
- Quality oversight of the relevant Service Providers and 3PL / 4PLs.
- Support of the Supply Chain in the shipping validation project
- Evaluation of the temperature excursions
- Training of GXP and Non GXP German Employees.
**Responsibilities**:
- Escalating GxP issues of Medicinal products’ handling & distribution compliance
- Involved in the management of Deviations, CAPAs and change control system
- Qualifying suppliers and customers; Suppliers audits and Quality Agreements
- Batch Document reception, review and archiving
- Investigational & marketed products’ batch confirmation under license E
- Cross-functional collaboration to support projects
- Management; support (incl. review and approval) the execution of the risk analysis.
- Together with other functions: responsible for product recall and ensure recall related notifications to the authority in case of adverse events or product quality issues and execute one mock recall annually (Art.6.5 GDP-LL).
**Supplier qualification**
- For suppliers relevant for Apellis Germany establish quality criteria for qualification of suppliers and develop quality questionnaires.
- Ensure qualification and release of suppliers and customers incl. requalification acc. to -4a Abs.2 Satz 3 AMHandelsV. Review quality questionnaires.
- Review and approve Quality Agreements and, or other agreements (technical agreements, service level agreements) together with other functions.
- Conduct Management Review Meetings, follow-up on status of (re)qualifications, prepare regular status reports of product and vendor performance, trending and agree upon metrics to ensure oversight.
**Audit and Inspection Management**
- Develop and ensure execution of the Annual Audit Program with Compliance Lead and SMEs
- Ensure timely follow-up on audit-related/derived tasks (e.g., CAPA plan)
- Perform suppliers' audits, internal audits, or coordinate the outsourcing of audits to external parties
- Ensure compliance to GxP across all activities at Apellis and readiness of the organization for inspections and audits
- Perform mock inspections as necessary
- Prepare and lead regulatory authority inspections and audits at Apellis; coordinate follow up activities in collaboration with the departments concerned, ensure timely submission of CAPA.
- Support audits/inspections of Apellis manufacturing partners and other external service providers, as needed
- Immediately report critical inspection and audit findings and non-compliances to executive management.
**Miscellaneous**:
- Has the authority of independent decision on Quality topics
- Perform all responsibilities for “Responsible Person” as described in SOPs
- Has the authority to recall product if deem necessary, coordinate activiti
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