APO QUALITY RESPONSIBLE PERSON

Abbott; Basel; Vor Ort; CHF 100’000 - 130’000; Vollzeit

Zusammenfassung

Abbott is seeking a Sr Specialist in Quality Assurance for their Allschwil site. The position entails maintaining regulatory compliance in the distribution of medicinal products while ensuring adherence to quality standards and providing support for various quality assurance processes. Ideal candidates have extensive experience in the pharmaceutical field and possess strong communication and teamwork skills.

Qualifikationen

• Minimum 5+ years in QA and/or Development/Operations/Pharmaceutical Engineering.
• Exposure as Qualified Person/Responsible Person is a plus.
• Fluent in English and German or French.

Aufgaben

• Maintain pharmaceutical license and Good Distribution Practices.
• Supervise complaints and manage product quality reports.
• Collaborate with stakeholders to ensure compliance in distribution.

Kenntnisse

Communication

Troubleshooting

Teamwork

Ausbildung

Degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering or other technical/scientific area

Master Degree

Tools

Quality Risk Management tools

Jobbeschreibung

JOB DESCRIPTION:

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.

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 ofall Standard Operating Procedures (SOP)related toGlobal 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 .

(If you want to upload several documents, don`t save in between uploading them to be able to do so. Once you save your uploads, you will not be able to add more documents)

Discover why candidates choose a career at Abbott Switzerland.

The base pay for this position is

N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Operations Quality DIVISION: EPD Established Pharma LOCATION: Switzerland > Allschwil : H-127 ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Yes, 10 % of the Time MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Not Applicable