Abbott Established Pharmaceutical Division (EPD) is looking for a

Sr Specialist Quality Assurance/Abbott Product Operations Responsible Person

Primary Job Function:

• Maintain Pharmaceutical License and GDP authorization for APO AG site, Allschwil, Switzerland.

• Perform duties of the ‘Fachtechnisch verantwortliche Person (FvP)’ in compliance with the Swiss ”Arzneimittel-Bewilligungsverordnung (AMBV)” and the Therapeutic Products Act (TPA, Heilmittelgesetz (HMG) to maintain the Swissmedic license of APO AG for EPD.

• Assure that the distribution of Medicinal products, Nutritionals, Cosmetics and Medical devices conform to Good Distribution Practices, Abbott Quality standards and other applicable regulatory standards.

• Assure that the Medicinal products sold and distributed in Switzerland conform to Good Distribution Practices, applicable Abbott Quality standards and applicable Swiss regulatory standards.

Core Job Responsibilities:

• Maintain Quality system at APO AG site as well as preparation and maintenance of all Standard Operating Procedures (SOP) related to Global Distribution and Logistics including (but not limited to): training, Internal audit program, document control, quality manual and quality management review.

• Complaint Management related to Global Distribution and Logistics.

• Supervise returns.

• Support market action process.

• Provide GDP support to the EPD Regions

• Manages qualification including selection, approval and management of Abbott’s Third Party warehouses (TPW), Logistic/Transport Service Providers (LSP/TSP), distributing global products to regions/affiliates and to-and-from GPMO sites as well as Third Party Laboratories engaged by APO AG and maintain Approved Supplier List.

• Provide the necessary support (i.e. training of applicable Abbott and regulatory standards) to service providers including but not limited to third party warehouses, Logistic/Transport Service provider.

• Ensure Bona Fides of customers for APO AG.

• Create overall Product Quality Review (PQR) reports for related products.

• Participate in Distribution projects, provide QA compliance.

• Work in close collaboration with APO AG’s stakeholders (i.e. Supply Chain, Global Distribution, Master Data, TPM/Supplier QA, Global Product Protection), to ensure GxP compliance in areas related to:

• Counterfeit

• Distribution Suppliers including performance management of Quality Key indicator parameters for global warehouses and distribution suppliers.

• Temperature Excursions & Temperature Monitoring process

• Product transport optimization and qualification

• Serialization

• Supply chain validation

• Material Listing approval

• Implementation of quality standards in areas of responsibility.

Minimum Education:

• Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area. Master Degree desired.

Minimum Experience/Training Required:

• Minimum 5+ years combined experience in QA and/or Development/Operations/Pharmaceutical Engineering function in Pharmaceutical environment.

• Prior exposure as Qualified Person/Responsible Person is a plus.

• Knowledge of Swissmedic regulations, EU GMP/GDP and other international legislations and standards, e.g. PIC/S, WHO, ICH.

• Experience in conducting and handling audits and inspections

• Troubleshooting and issues resolution skills.

• Ability to communicate effectively, both orally and in writing to both internal and external audience.

• Teamwork attitude.

• Ability to use Quality Risk Management tools.

• Fluent English and German or French.

• Ability to travel in all continents (10%).

Do you like the sound of this job and think you’ve got what it takes? Then send us your CV today. We look forward to receiving your application as pdf.

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