Senior QA Compliance Expert

vor 1 Woche

Basel, Basel-Stadt, Schweiz Arcondis Group Vollzeit CHF 100'000 - CHF 120'000 pro Jahr

Job Overview

For our Swiss and EU based pharmaceutical clients we are seeking an experienced Senior QA Compliance Specialist fulfilling also the requirements to act as "Fachtechnisch verantwortliche Person (FvP)" according to Swiss Arzneimittel-Bewilligungsverordnung (AMBV), as well as "verantwortliche Person Betäubungsmittel) according to Swiss Betäubungsmittelkontrollverordnung (BetmKV).

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:
  • 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 execution of audits and inspections
  • Assessment of pharmaceutical law requirements when importing medicinal products
  • Review and approval of GxP-relevant SOPs
  • Approval of critical deviations, OOS and complaints related to the marketed products
  • Execution of recalls related to the marketed products
  • Execution of 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

Qualifications, Skills and Experience

  • University degree in pharmacy or closely related science field
  • Fulfillment of the requirements as FvP as per Swiss AMBV
  • Fulfillment of the requirement as vP Betäubungsmittel as per Swiss BetmKV
  • At least 5 years of active work in quality management, preferably in the pharmaceutical industry
  • Ideally work experience as FvP according to Swiss Arzneimittel Bewilligungsverordnung (AMBV)
  • 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, French beneficial

Why Arcondis

  • An opportunity to shape the future of healthcare by spearheading transformative deals
  • A collaborative and innovative work environment where your ideas are valued, and your contributions make a significant impact
  • Flexible working environment, enabling work-life balance
  • Attractive compensation package, inclusive of performance-based incentives that reward exceptional achievements
  • Professional growth and development opportunities

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