Responsible Person Apellis Germany - Munich, Deutschland - Apellis Pharmaceuticals

Apellis Pharmaceuticals

Geprüftes Unternehmen

Munich, Deutschland

vor 3 Wochen

Geschrieben von:

Lena Wagner

beBee Recruiter

Beschreibung

Position
:
Deputy 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.

Main task (Key Accountabilities):

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 ).
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 ensure 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.
Ensure appropriate Product Complaint Handling (Art. 6.2 GDP-LL).
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.

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.

Divers

Perform all responsibilities for "Responsible Person" as described in SOPs
Responsible for recalls, coordinate activities and establish CAPAs as necessary
Act as contact person for all GDP related aspects to quality for any request coming from the Apellis QP or from the QP of any other supplier.
Establish trusted relationships with national health authorities (Regierung von Oberbayern, BfArM, etc...)

Competencies:

Excellent analytical skills paired with a proactive and actionoriented attitude in driving for results to meet program and project
Management: develops and leads, on a consistent basis, wellaligned quality strategies that win commitment for key initiatives, inside and outside the
Customer Orientation; cultivates a deep, proactive understanding of internal and external customers and requirements and goals across Apellis organization. Possesses a customer/ clientcentric mentality and a passion for
Analytical, strategic and conceptual thinking which is coupled with problem solving, creative thinking and
A low ego leader who operates with a purpose aligned to patientcentric values.
Excellence in communication and leads through influence not an autocrat and able to leverage the
Must have significant adaptability and resilience. Must be able to get to th