Quality Assurance Officer

Quality Assurance Officer

Mundipharma

Basel, Switzerland

Role and Responsibilities:

Quality management System oversight

• Accountable for an effective QMS being established/implemented, maintained and operated in line with current GDP & GMP requirements, local regulatory standards, and Mundipharma standards for all relevant product classes.
• Perform and follow-up activities related to Quality Management Systems
• Accountable for maintenance and operation of local GxP change controls, deviations and CAPAs.
• Accountable for appropriate receiving and handling of complaints, (suspected) product defects, temperature excursions and (suspected) falsified medicinal products, security incidents, product recalls, adverse drug reactions and other safety information.
• Support Independent Associated Companies regarding Quality related topics.
• Support Quality Management Reviews and other regular reports to the upper Management

​Outsourcing and Technical Agreements

• Mantain and updating Technical Quality Agreements with Suppliers and Customers
• Escalation of significant Quality issues to the superior.
• Inspections/audits and quality defects
• Support and perform adequate Supplier, Customer and Service provider qualification activities including audits.
• Implement and assure an adequate Self Inspection system.
• Management of Third Party providers by:
• Writing new Technical/Supplier agreements
• Reviewing Periodic Quality Reviews
• Review of third party Change Control, Deviations, CAPA and Complaints using risk management principles
• Participate and work collaboratively with internal and external stakeholders on issue resolution to ensure product quality, compliance and supply.
• Establish effective partnership and relationship with third parties.

What you’ll bring:

• Bachelor's degree in chemistry or related
• Professional whose career is related to pharmacy
• A minimum of 2 years’ experience in GxP (e.g. GMP, GDP)
• GDP knowledge of pharmaceutical products, medical devices and narcotic/psychotropic products, cosmetics, biocides, foods, etc.
• Proficient in establishing and maintaining a GDP/GMP Quality Management System
• Trained auditor for GDP/GMP (or at least acting as co-auditor).
• Experience in a QA role, particularly in managing pharmaceutical Quality Systems.
• Managing outsourced activities and third-party service providers
• Hosting of GxP inspections
• Working in an international setting
• Working with narcotic/psychotropic products

Knowledge and Skills

• Desirable - Knowledge in national and international pharmaceutical legislation.
• Proactive, pragmatic, independent, organized and self-confident.
• Customer focused and cross-functional thinking and behavior.
• Works collaboratively maintaining good working relationships with cross functional teams and partners actively participating contributing to team success.
• Proficient in the use of Microsoft Office applications
• Competent in use of databases (preferred)
• Experience of Supplier Management (preferred)
• Fluent in spoken and written English. Regional language (German) preferred.

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