Batch Release

Summary

• Deputy Responsible Person for the maintenance of applicable Operational Licenses.
• Responsible for the implementation and maintenance of Quality Management System required as per local regulations and standards.
• The Responsible Person is the main contact for Quality Assurance (QA) topics to distributors and external bodies.

Responsibilities

• To ensure Quality Assurance related compliance with all National and International Regulations and internal regulations. Focusing on the management of authorized activities, the accuracy and quality of records.
• To ensure that all medicinal products are handled appropriately, in particular as it concerns the monitoring of product specification (including Certificates of Compliance), testing instructions, storage conditions, expiry dates and quality standards.
• Perform final release of batches to the Swiss market according to local legislation. Decide whether a batch is released to European market or not independently from Management and Leadership Team.
• Develop, implement and maintain local procedures according to local regulations and Global QMS.
• Lead and coordinate Quality Management Reviews
• Host internal Affiliate Audits and coordinate and lead related follow-ups and CAPA development and implementation

Requirements

• Experience in the Pharmaceutical Industry, at least 3 years in the field of QA/RA.
• Track record in the field of QA including registrations, audits & inspections.
• Good knowledge of German language. Fluent in English (speaking & writing).
• Higher education in pharmaceutical or natural sciences. Minimum of Master Level, preferably PhD or Pharmacist.