Job Detail

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Job Titel

QA Supplier Specialist

Job Beschreibung

Your Role:

Reporting to QA Supplier Manager, this role does serve as the Single Point Of Contact to ensure that Suppliers do deliver reliably and consistently goods or services used in GMP/GDP related activities for commercial products, in accordance with Ferring’s Quality requirements  and applicable regulatory requirements.

Main responsibilities :

• Apply and develop Supplier Quality management process according to Corporate & Local SOPs and according to cGxPs. “Suppliers” does include API,Excipients, Packaging Materials and Medical Device Suppliers


• In a timely manner, assess Quality Events (Deviation ,CAPA or Change related to Suppliers. Establish and maintain direct contact with Suppliers to improve Quality of goods or services


• In a timely manner,perform the annual Quality performance evaluation of Suppliers and update Supplier’s assessment record accordingly:Ensure data available for annual Business Review Meeting


• Implement and update Quality Technical Agreement with Suppliers and provide support for writing and updating of corresponding specifications


• Prepare and conduct Suppliers audits according to Corporate & Local SOPs and to annual audits plan or for cause decision.Issue audit reports, follow and close CAPA from audit observations


• Identify Process gaps and/or Quality issues in activities, propose opportunities and lead actions including KPIs set up


• Participate and support Health Autorities Inspection and customer audits

Required Experience & Competences :

• Minimum Bachelors’ degree or equivalent in science or in related discipline with 5 to 10 years of relevant and successful experience in a related industry with significant experience in QA activities


• Knowledge of relevant Medical Devices standards / regulations would be an asset


• Strong Suppliers / Customers orientation and ability to set up links between internal and external partners


• Ability to gather, analyse and interpret a wide range of information/data and develop rationale for pragmatic recommendations /decisions


• Fluent in English and French both written and spoken


• Strong interpersonal skills in dealing with all levels of management


• Effective communication skills both verbal and written and the ability to assess risks and shape decision making


• Demonstrate strong organizational skills and work with minimum supervision, good initiative and follow up

Ort

Switzerland SMP - St Prex </div>

Job Titel

QA Supplier Specialist

Job Beschreibung

Your Role:

Reporting to QA Supplier Manager, this role does serve as the Single Point Of Contact to ensure that Suppliers do deliver reliably and consistently goods or services used in GMP/GDP related activities for commercial products, in accordance with Ferring’s Quality requirements  and applicable regulatory requirements.

Main responsibilities :

• Apply and develop Supplier Quality management process according to Corporate & Local SOPs and according to cGxPs. “Suppliers” does include API,Excipients, Packaging Materials and Medical Device Suppliers


• In a timely manner, assess Quality Events (Deviation ,CAPA or Change related to Suppliers. Establish and maintain direct contact with Suppliers to improve Quality of goods or services


• In a timely manner,perform the annual Quality performance evaluation of Suppliers and update Supplier’s assessment record accordingly:Ensure data available for annual Business Review Meeting


• Implement and update Quality Technical Agreement with Suppliers and provide support for writing and updating of corresponding specifications


• Prepare and conduct Suppliers audits according to Corporate & Local SOPs and to annual audits plan or for cause decision.Issue audit reports, follow and close CAPA from audit observations


• Identify Process gaps and/or Quality issues in activities, propose opportunities and lead actions including KPIs set up


• Participate and support Health Autorities Inspection and customer audits

Required Experience & Competences :

• Minimum Bachelors’ degree or equivalent in science or in related discipline with 5 to 10 years of relevant and successful experience in a related industry with significant experience in QA activities


• Knowledge of relevant Medical Devices standards / regulations would be an asset


• Strong Suppliers / Customers orientation and ability to set up links between internal and external partners


• Ability to gather, analyse and interpret a wide range of information/data and develop rationale for pragmatic recommendations /decisions


• Fluent in English and French both written and spoken


• Strong interpersonal skills in dealing with all levels of management


• Effective communication skills both verbal and written and the ability to assess risks and shape decision making


• Demonstrate strong organizational skills and work with minimum supervision, good initiative and follow up

Ort

Switzerland SMP - St Prex