Description
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
QA Compliance Expert in Eschborn Arbeitgeber: ARCONDIS
Als Arbeitgeber im Bereich Life Science Compliance bieten wir Ihnen die Möglichkeit, in einem dynamischen und innovativen Umfeld zu arbeiten, das auf Qualität und Exzellenz ausgerichtet ist. Unsere Unternehmenskultur fördert Teamarbeit und kontinuierliche Weiterbildung, sodass Sie Ihre Fähigkeiten weiterentwickeln und Ihre Karriere vorantreiben können. Zudem profitieren Sie von flexiblen Arbeitszeiten und einer attraktiven Vergütung, die Ihre wertvolle Arbeit in der pharmazeutischen Industrie anerkennt.
