Senior QA Compliance Consultant – Pharma (Basel Area)

Arcondis Group

Basel

On-site

CHF 120,000 - 180,000

Full time

3 days ago
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Benefits offered by this job

Flexible working environment
Attractive compensation package
Professional growth opportunities
Performance-based incentives

Job summary

Arcondis Group in Basel area is seeking a skilled QA Compliance Expert Freelancer to advise clients on QA/Compliance in pharmaceutical contexts. You will execute projects and support audits, registrations, and BetmKV-related tasks.

Ideal candidates have 5+ years in quality management in pharma, strong knowledge of Swiss and international pharma law, and fluency in German and English. This role offers client-facing responsibilities and opportunities to shape QA services at Arcondis.

Qualifications

  • 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 required, additional language beneficial.

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

Skills

Quality management
Independence
Leadership
German-English fluency

Education

University degree in pharmacy or related science
vP narcotics (Swiss BetmKV)

Job description

Arcondis Group in Basel area is seeking a skilled QA Compliance Expert Freelancer to advise clients on QA/Compliance in pharmaceutical contexts. You will execute projects and support audits, registrations, and BetmKV-related tasks.

Ideal candidates have 5+ years in quality management in pharma, strong knowledge of Swiss and international pharma law, and fluency in German and English. This role offers client-facing responsibilities and opportunities to shape QA services at Arcondis.

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