QA Compliance Expert

Arcondis Group; Basel; On-site; CHF 120,000 - 180,000; Full time

Benefits offered by this job

Flexible working environment

Performance-based incentives

Professional growth opportunities

Competitive compensation

International exposure

Job summary

Arcondis Group seeks a skilled QA Compliance Expert for our Swiss and EU based pharmaceutical clients. You will consult on QA aspects, execute client projects, and ensure compliance across the value chain including inspections and regulatory interfaces.

The role requires a university degree in pharmacy or related field, fluency in German and English, and a track record in quality management within pharma. You will contribute to BetmKV tasks and develop QA capabilities in a collaborative

Qualifications

• University degree in pharmacy or closely related science field.
• Very good written and spoken German and English skills required.
• Independence, willingness to take responsibility and decisiveness.

Responsibilities

• Consulting of clients in Quality Assurance/Management aspects.
• Execution on client projects in QA/Management.
• Support market release/non-release decision of pharmaceutical products.
• Ensure compliance with Swiss BetmKV and GxP-relevant SOPs.
• Interface to local competent authorities and audits/inspections.
• Manage deviations, OOS and complaints related to marketed products.
• Recalls related to the marketed products and self-inspections.

Skills

German language proficiency

English language proficiency

Communication

Independence

Education

Pharmacy degree

Job 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

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 required, additional language 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