Agile Software Tester improving software quality in complex systems at beQualified, focusing on testing processes and collaboration with developers.
About the role
- Lead Expert in Quality Assurance at Octapharma managing regulatory compliance and market releases. Role includes supporting pharmacovigilance and quality assurance tasks in a pharmaceutical environment.
Responsibilities
- Responsible for the compliance check of the batches intended for the Swiss market and for the administrative market release.
- Acting as interface between Swissmedic and the Corporate Regulatory Department to organize new/maintain existing Marketing Authorizations of the products.
- Fulfilling the required tasks in Pharmacovigilance as Deputy Local Drug Safety Officer for Switzerland/Liechtenstein.
- Giving support in various Quality Assurance tasks (eg. Document Management System, internal auditing, employees training, GxP tasks like handling of change controls, deviations, CAPA, returns, PQR review, qualification of service providers, etc.).
- During the absence of the Responsible Person and where immediate action is required, the deputy RP takes over the activities and role of Responsible Person.
- Responsible for compliance with the regulatory requirements (Swiss laws (TPA, TPLRO, MPLO etc), GMP, GDP and other relevant EU Guidelines) within the framework of the Establishment License (authorization) of Swissmedic.
Requirements
- You have a pharmaceutical / life science background (Master).
- Preferably several years of experience in a role in the pharmaceutical industry, if possible, in a Quality Unit.
- Experience in Regulatory affairs and/or Pharmacovigilance are advantageous.
- You have excellent organizational skills, and the ability to manage multiple projects.
- You bring a drive for excellence and a positive “can do” approach.
- You are exact and accurate; you have a keen eye for detail and the confidence to provide support when needed.
- You are fluent in German and very good in English (written/spoken); basic written/spoken French is a plus.
Benefits
- Be rewarded with market-related salary and benefits package
- Skills development - We offer various internal and external employee and leadership trainings, trainee programs and digital solutions
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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