GxP Compliance Expert

ITech Consult AG; Kaiseraugst; Vor Ort; CHF 120.000 - 160.000; Vollzeit

Zusammenfassung

ITech Consult AG seeks a senior GxP and quality compliance expert to guide the business in regulatory topics and inspections. You will oversee deviations, CAPAs, changes, and process improvements while managing SOPs and regulated documents. Training will raise the team’s GxP knowledge across the organization.

The role requires a degree in a relevant field and at least six years of senior experience, with fluency in German and English. You will work within a Swiss environment in Kaiseraugst.

Qualifikationen

• Degree in a relevant field with extensive senior experience.
• Strong knowledge of cGMP and regulatory inspections.
• Fluent German and English, excellent communication skills.

Aufgaben

• Provide proactive advice on GxP and compliance topics, incl. system administration.
• Own quality KPIs and deviations, CAPAs, changes and process improvements.
• Lead deviation management improvements and root cause analysis.
• Manage SOPs and regulated documents across the department.
• Deliver training to enhance employees' GxP knowledge and compliance.

Kenntnisse

GxP Compliance

Audit Management

CAPA & Deviation Handling

Ausbildung

BA/MS/MBA in a relevant field

Tools

Veeva

MS Office

Jobbeschreibung

• SME for all GxP and compliance-related topics (proactive advice on these matters) incl system administration (Veeva quality docs)
• Audit/Inspection SME for Deliver for non-study specific examinations
• Processing of deviations as well as CAPAs, Changes, Process Improvements
• Quality KPI Ownership for Deliver
• Responsibility for deviation management improvement processes
• Offer comprehensive compliance expertise to the business, conducting Root Cause Analysis (RCA) to identify and address quality, regulatory and compliance-related issues
• Managing the structure for the departments‘ SOPs and any other regulated documents (The business know-how is provided by the chapter’s SMEs)
• Responsibility for trend reporting across Quality and Compliance requirements
• Implementation of GxP training and further development of employees‘ GxP knowledge

Must Haves:

• You hold a degree (BA, MS, MBA) in a relevant field (e.g. Supply Chain Management & Logistics, Pharmacy, Biology, Chemistry, Industrial Engineering and Management), backed by significant expertise and extensive years of senior professional experience.
• At least 6 years of professional experience
• You possess extensive knowledge of cGMP standards alongside hands‑on experience navigating internal (PTQ, Pharma‑Technical Quality) and external (e.g., FDA, EMA) regulatory inspections.
• You bring a deep understanding of end‑to‑end supply chain management, specifically encompassing warehouse and transportation management, logistics, and clinical supply chain distribution processes.
• You demonstrate strong interpersonal, communication, organisational, and prioritisation skills with a steadfast focus on customer needs.
• You are fluent in both written and spoken German and English.
• You are proficient in using Google applications, MS Office (Word, Excel, PowerPoint), Visio, and key industry systems such as Veeva and Cornerstone.