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Regulatory Affairs & Quality Assurance Manager   

Standort: Schweiz, Tessin, Lugano

Daten 06/07/2018

Branche: Pharma-Industrie

Funktion: Anderes

Aktivitäten 

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Our client is an international pharmaceutical company based in Lugano and authorised with ambitious plans to keep improving and growing. For this exclusive research, we are looking for a successful candidate to fill the position of:

 

Regulatory Affairs & Quality Assurance Manager

 

The purpose of the job is to:

- Managing Quality System: application, control and development.

- Planning strategies and policies of quality in cooperation with the management and in accordance with the applicable regulations (GDP, ISO 9001:2015, ISO 13485:2016, ISO 22716:2007).

- Specifying quality requirements of suppliers and managing supplier qualification.

- Writing quality, regulatory and technical reports.

- Planning quality improvement programs in cooperation with all business functions.

- Managing of complaints, non-conformities, deviations, change controls and CAPAs.

- Supporting the inspections of Swiss authorities and/or customers; answering to inspection reports.

- Managing Regulatory activities to register products in the European Union.

- Responsible for the Surveillance and Vigilance System for drugs and Medical Devices.

 

Description:

The following skills will be considered a plus:

- Being able to qualify as Responsible Person duties described in art. 5, art. 10, art. 14 and art. 15 of the ELO Ordinance on Establishment Licenses (SR 812.212.1).

- Knowledge of Regulatory Affairs related to Medical Devices, cosmetics and dietary supplements.

- Knowledge of the regulatory environment of United States related to Medical Devices and cosmetics.

 

The Regulatory Affairs & Quality Assurance Manager will report to the Sole Director.

 

Requirements

- Education: University or equivalent higher institute graduation in pharmaceutical or biological-natural sciences.

- At least 4 years of professional experience in a licensed production of medicines; proved experience and knowledge of GMP/GDP. Or at least is in possession of qualifications as stated in I-SMI.TI.17.

- Competent in quality management system matters, analysis and control of medicinal products, medical devices, cosmetics and food supplement products.

- Formally trained and up to date on EU GDP requirements, ISO standard 13485, 22716, 9001.

- Ideally age between 36 and 43 years.

- Language: fluent English and Italian, written and spoken.

 

Interested candidates should send their CV by email to Cristina Robotti at infoluisoni@luisoni.ch or by post to the address below. For further information please call the following number: +41 91 911 30 00.
 

We thank all applicants for their interest, but only candidates selected for an interview will be contacted.

MAXIMUM DISCRETION AND PROFESSIONALISM FULLY GUARANTEED!

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Anstellungsart: Dauerhafte Arbeit

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