Könyvelő program állások Németországban (minőségbiztosítás)

Plan, Conduct, and Follow Up on Pharmacovigilance Audits including oversight and training of external service providers and consultants (for audits), ensuring adherence to company standards and regulatory requirements...

• Plan and Conduct GCP Audits: Develop a risk-based audit schedule covering all relevant areas, including investigator sites, vendors, and internal processes, to ensure adherence to GCP guidelines
• Oversee Corrective and Preventive Actions (CAPA) specific to GCP (internal or external)

Creation, editing, and review of all quality documents (DEV, CAPA, CCO, maintenance completion reports) in accordance with SOP specifications...

• Global pharmacovigilance product responsibility for the medicinal products
• Monitoring of the benefit-risk profile
• Signal management: signal detection, signal validation, signal evaluation
• Risk management: preparation of risk management plans, supervision of risk minimization measures

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

• Batch record review for API and bulk product for monoclonal antibody prefilled syringes
• Assessment and documentation of product deviations, OOS, and changes
• Quality oversight for relevant service providers, including CMO's, laboratories, technical operations and supply chain

• Scientific lead and coordination of Critical Quality Attributes (CQA) evaluations and product characterization studies
• Representation of Analytical Science in the customer project teams, coordination of activities and implementation of the QbD strategy

Create and/or hold scientific presentations, lectures, training courses, speaker decks, FAQ documents etc. with targeted content for the respective stakeholders...

Define and lead the global Clinical Affairs strategy for Brainlab's global surgery portfolio, ensuring alignment with product, regulatory and commercial objectives / teams...

• Coordinate alliance management activities and ensure adherence to contractual commitments
• Support (and later) lead contract-related updates, including tracking and initiating required changes
• Contribute to achieving key alliance business objectives

Independent realisation of production processes: Responsible execution of filtrations and chromatographic applications in production scale (250 to 1000 litres), according to the specifications for the GMP environment...