Associate Quality Assurance

vor 1 Monat

CH Basel SFL Regulatory Affairs & Scientific Communication GmbH Vollzeit

Would you like to join and contribute to a successful and growing multi-national organization in the heart of Europe and one of the world’s leading regions of the pharmaceutical industry?

SFL, a Veristat company, and its dynamic cross-functional team provide premium consulting support to companies in the healthcare and life sciences fields. Our clients range from vibrant start-ups to established top 10 pharma and medtech companies.

We have an opening for an Associate in Quality Assurance & Pharmacovigilance for our head office in Basel, Switzerland.

Core responsibilities

· Support QA & PV team in creation and implementation of quality management system for clients

· Support QA & PV team in preparing for self-inspections, external audits, and health authority inspections

· Support maintenance of SOPs and other quality-related documents

· Support management and oversight of change controls, deviations, CAPAs or other quality processes

· Support local PV activities including literature reviews

· Maintaining awareness of global drug safety for assigned products, as well as PV regulations and guidelines.

· Support collection of AE case reports and reconciliation of collected data

· Support PV team in handling of individual case safety reports (ICSRs), periodic safety update reports (PSUR), risk management plans (RMP) and communication of safety-related information to health authorities

Qualifications and requirements

· Bachelor/Master/PhD in Pharmacy or in Life Sciences

· Interest to develop knowledge in GMP, GDP, and GVP

· Interest on quality and PV processes

· Analytical and systematic thinking, organization skills, and flexibility

· A highly motivated and open-minded personality, able to work in an international and growing environment

· Excellent communication skills

· Excellent skills in English and German is a must (verbal and writing)

SFL offers

· A stimulating role in a growing and dynamic organization

· Work in an international, energetic, motivated team

· Continuous development and training opportunities

· Office- or home-based working

· Rewards for outstanding accomplishments

About SFL

We provide innovative and customized services and solutions in the field of life sciences from offices in Switzerland and the EU. Our main areas of expertise are Regulatory Affairs, Medical Affairs, Quality Assurance & Supply Chain, Market Access, Public Affairs, Pharmacovigilance, and Legal & Compliance.

Expertise, innovation, development, respect and ethical behavior are our values and corner stones of our company culture and key to our success and excellent reputation. We are a rewarding company with an excellent environment to grow.

If you are interested in this position, please share with us your application with CV, motivation letter and references here.

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