QA Specialist Within QA for Logistics & Transport and Global Wholesale

Description

The candidate will be part of the QA team for Logistics & Transport and Global Wholesalers within Global IMP Quality Supply Chain accountable for the quality oversight of two

Operational areas:
The Logistics & Transport Department located in Basel and Kaiseraugst,
The companies used to source comparator products for clinical studies, globally.

Key Responsibilities:

Working in close collaboration with the Logistics
Ensure adherence to the Company's Quality System;
Develop Quality Management strategies for transport and distribution;
Support the qualification of Logistic Service Providers (LSP) used by PSSL (via risk assessment and audits);
Establish and manage Supplier Quality Agreements with LSPs;
Supervise the transport verification for different distribution lanes;
Participate in the regular supplier performance meetings;
Oversight the discrepancy management system at Logistics
Manage, monitor and trend changes and CAPAs;
Support audit readiness;
Support GDP self-inspections at PSSL;
Support qualification activities of storage areas (eg review/approval of URS, DQ, IQ, OQ, PQ) and their maintenance/decommissioning.
Assist the team with the management and qualification activities of shipping systems;
Supervise the cleaning and pest control program of the logistic hubs Basel and Kaiseraugst;
Assist the team with the management and qualification activities of global wholesalers;
Continuously monitor the quality management system to guarantee continuous improvement within the area of responsibility;
Develop or maintain GMP documentation for the team.

Who you are:

You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies.
Where a job title is not considered the final definition of who you are, but the starting poin

For this interesting position you bring the following qualifications:

Qualification and Requirements:

University degree in natural science;
At least 5 years' experience in the pharmaceutical industry, preferred in quality assurance;
Very good knowledge and working experience in EU and international regulations (eg WHO, EU-GDPs, GMPs). GMP/GDP and logistics knowledge is required (certificates should be included);
Experience with validation/qualification activities (certificates should be included);
Proven audit experience (certificates should be included in CV);
Ability to communicate in German and English, both orally and in writing is mandatory;
Good computer skills (Word, Excel, Visio) are a must;
TrackWise and risk management knowledge (eg TCM, gDMS) is a plus;
Strong interpersonal and communication skills dealing in a multicultural environment;
You are motivated, enthusiastic and solution-oriented mind-set;
You are a team player, well organized and have the capacity to work independently and under pressure.