Responsible Person Germany - Munich, Deutschland - Apellis Pharmaceuticals

Apellis Pharmaceuticals

Geprüftes Unternehmen

Munich, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

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 Stufenplanbeauftragter / 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
Crossfunctional 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, followup 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 followup on auditrelated/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 noncompliances to executive management.

Miscellaneous: