Senior QA Compliance Expert

Project Services - Basel

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Your profile / requirements

• 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

Tasks and 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

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