Job Detail

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Job Titel

Quality Management System Senior Specialist

Job Beschreibung

Your Mission:

Manage, define, maintain and improve quality system related to the GxP activities.

Your Main Responsibilities:

• Ensure definition of corrective and preventive actions with process owner, and follow the implementation and effectiveness in due time


• Ensure effectiveness of the CAPA management trough QMS including ICHQ9 approach


• Ensure investigations and deviation assessment trough GxP processes, including risk approach evaluation


• Manage Health Authorities inspections and customer audit


• Manage internal audits system to ensure those are planned and executed and are defined in accordance to the quality risk management of the site


• Lead internal audits (self-inspection)


• Prepare and analyse the quality trends to ensure Quality System are implemented, compliant and effective according to site objectives and Quality Plan


• Ensure and support the implementation of Corporate Guidelines on local GxP activities


• Give support and coaching to other departments to implement and maintain cGMP compliance, (daily business activities, sop, training…)


• Participate in QRM to make the link with other Quality System

Required Experience & Competences:

• Scientific degree (pharmacy, chemistry, biology or related field)


• Minimum 5 to 10 years of relevant experience in within pharmaceutical industry and GMP environment (mandatory), ISO 13485 experience is a plus


• Strong experience in cGMPs and regulatory inspection (at least EU and US) in QA department


• Good knowledge in laboratory activity


• Good knowledge of ICHQ9 and Q10 guidelines


• French mother tongue and fluent in English (min C1 – advanced level)


• Attentive to details, team worker


• Ability to handle several tasks simultaneously and with high accuracy


• Positive thinking, enthusiasm and commitment

Ort

Switzerland SMP - St Prex