GxP Coordinator

Description

Document & process governance

• Maintain, file and archive original GxP documentation to meet retention, retrievability and audit/inspection requirements. Maintain the respective sharepoint sites
• Coordinate creation, maintenance and controlling of SOPs, work instructions and checklists for Stufenplan, Information and Wholesale responsibilities.

Regulatory & authority liaison

• Prepare, coordinate and respond to authority correspondence, notifications and information requests; ensure timely, compliant responses – in coordination with the respective stakeholders
• Support GxP audits and inspections and related follow-up activities; maintain inspection logs and evidence; coordinate CAPA tracking and closure.

Role administration & support

• Maintain lists of responsible persons and contact details for GxP roles; coordinate handovers and rolerelated documentation.
• Support role holders in executing required processes and documentation and coordinate these activities.
• Together with other GxP functions, evaluate the adequacy of potential new candidates for GxP relevant roles acc. to German Drug Law, when and if required, before submission to the authorities

Compliance monitoring & change impact

• Track national (and EU) changes in regulations, guidances and legislation; perform impact assessments and implement required process updates. Reporting & management information
• Produce regular compliance reports and KPIs for local management (document status, open actions, inspection readiness).

Training & stakeholder advice

• Provide training and advisory support for employees and partners on GxP procedures and regulatory requirements.

Wholesale & GDP-related tasks

• Support GDP controls for wholesale activities (license checks, distribution documentation, traceability), when needed.

Graduated Plan Officer support

• Support the Graduated Plan officer(-s) during ad hoc activities, e.g. crisis situations: Tasks may include: Organising meetings, preparing agendas, writing minutes, administration of documentation, preparation of communication

Working conditions

• Travel as needed to support inspections or regulatory meetings.
• Possible oncall availability for critical regulatory events

Qualifications

• Relevant qualification with GxP experience and / or degree in Pharmacy, Life Sciences, Biotechnology, Natural Science or equivalent
• ideally practical experience in a GxP environment; experience with Stufenplan/Information officer/Wholesale processes is a plus.
• Solid understanding of GxP and national/EU regulatory frameworks.
• ideally experience supporting inspections/audits and working with CAPA systems.
• ideally familiarity with QA systems, CAPA/issue tracking and preparing compliance reports/KPIs.
• Proficient with document management systems and MS Office.
• Behavioural & technical competencies
• Structured, process-oriented, and detail-focused.
• Action- and goal oriented