\\nJOB 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 \\xe2\\x80\\x98Fachtechnisch verantwortliche Person (FvP)\\xe2\\x80\\x99 in compliance with the Swiss \\xe2\\x80\\x9dArzneimittel-Bewilligungsverordnung (AMBV)\\xe2\\x80\\x9d 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\\xe2\\x80\\x99s 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\\xe2\\x80\\x99s 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: knowledge of other language is a plus

Ability to travel in all continents (10%)

Do you like the sound of this job and think you\\xe2\\x80\\x99ve 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)

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\\n \\n \\n \\n \\n \\n

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