QA Compliance Expert

Arcondis Group; Basel; Hybrid; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

Arcondis Group is seeking a QA Compliance Expert to join our Basel-based team. The role focuses on consulting clients in QA/Management, ensuring GMP compliance, and supporting market release decisions across the Swiss market.

You will cover audits, inspections, and liaison with authorities, develop QA capabilities, and lead deviations, OOS, and recalls processes. The ideal candidate has a pharmacy degree, 5+ years in QA, and fluent German and English.

Qualifikationen

• University degree in pharmacy or closely related science field.
• 5+ years of active work in quality management, preferably in the pharmaceutical industry.
• In-depth knowledge of Swiss national and international pharmaceutical law.
• Excellent communication across hierarchies, disciplines and cultures.
• German and English language skills (written and spoken) with additional languages beneficial.

Aufgaben

• Consulting of clients in all kind of Quality Assurance/Management aspects.
• Execution on client projects in the area of Quality Assurance/Management.
• Execution of all tasks arising from the AMBV, in particular:
• Support market release/non-release decision of pharmaceutical products
• Ensuring the required quality of the pharmaceutical products marketed in Switzerland along the whole value chain, i.e. procurement, production, quality control, warehousing and distribution
• Interface to the local competent authorities
• Ensure compliance with actual product registration files
• Preparation and support of audits and inspections
• Assessment of pharmaceutical law requirements when importing medicinal products
• Review and approval of GxP-relevant SOPs
• Manage deviations, OOS and complaints related to the marketed products
• Recalls related to the marketed products
• Self-inspections in relation to the above-mentioned responsibilities
• Execution and oversight of all tasks arising from BetmKV
• Support business development activities in the QA compliance area
• Contribute to develop the QA compliance services and capabilities according to market needs and trends
• In case of FvP qualifications: Support of local FvP in all FvP related areas

Kenntnisse

5+ years QA experience

Quality management

German & English pk/l

Communication skills

Independence & responsibility

Regulatory knowledge

Ausbildung

University degree in pharmacy or closely related science field

Jobbeschreibung

QA Compliance Expert - (RD_QMS_SDL_0003.1)

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Requisition #

RD_QMS_SDL_0003.1

Job Title

QA Compliance Expert

Contract Type

Full Time

Category

Consulting

Location

Overview

For our Swiss and EU based pharmaceutical clients we are seeking a skilled QA Compliance Expert .

Key Responsibilities

• Consulting of clients in all kind of Quality Assurance/Management aspects
• Execution on client projects in the area of Quality Assurance/Management
• Execution of all tasks arising from the AMBV, in particular:
• Support market release/non-release decision of pharmaceutical products
• Ensuring the required quality of the pharmaceutical products marketed in Switzerland along the whole value chain, i.e. procurement, production, quality control, warehousing and distribution
• Interface to the local competent authorities
• Ensure compliance with actual product registration files
• Preparation and support of audits and inspections
• Assessment of pharmaceutical law requirements when importing medicinal products
• Review and approval of GxP-relevant SOPs
• Manage deviations, OOS and complaints related to the marketed products
• Recalls related to the marketed products
• Self-inspections in relation to the above-mentioned responsibilities
• Execution and oversight of all tasks arising from BetmKV
• Support business development activities in the QA compliance area
• Contribute to develop the QA compliance services and capabilities according to market needs and trends
• In case of FvP qualifications: Support of local FvP in all FvP related areas

Requirements

Qualifications, Skills and Experience

• University degree in pharmacy or closely related science field
• Fulfillment of the requirement as vP narcotics as per Swiss BetmKV
• At least 5 years of active work in quality management, preferably in the pharmaceutical industry
• In-depth knowledge of Swiss national and international pharmaceutical law, as applicable
• Excellent communication across hierarchies, disciplines and cultures
• Independence, willingness to take responsibility and decisiveness
• Very good written and spoken German and English skills, additional language beneficial