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Become part of a vital chain and contribute to our common goal of making people’s lives better. Headquartered in Lachen, Switzerland, Octapharma is one of the largest human protein manufacturers in the world, developing and producing medicines sourced from human plasma and human cell lines. We are a privately-owned company, where the warmth of family meets the scale of a global organisation.

Join us in shaping our vision to provide new health solutions advancing human life.

Your main tasks and 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.

Your expertise and ideal skill set

• 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.

Your department - where you make an impact

• The Quality Assurance unit at Octapharma AG is a small team in charge of GDP compliance for the Swiss market. Additionally, there are corporate oversight tasks and responsibilities, being Octapharma AG the Headquarter of the Octapharma group. You’ll work in an international environment and be in touch with the different affiliates of Octapharma all over the world.
• You will support in your role the Responsible Person, the deputy Responsible Person and the Associate Expert Quality Assurance Documentation.
• This position is part-time (50-60%).

Thrive with us

• You help save lives - Every day is meaningful as we produce life-saving medicines
• Family values - Long-term perspective for employees and relationships
• Be rewarded with market-related salary and benefits package
• You will have a high level of influence where you can make a difference and leave your footprint
• Work with skilled and fun colleagues in a relatively informal organization
• Skills development - We offer various internal and external employee and leadership trainings, trainee programs and digital solutions
  
  

It´s in our blood

We live diversity and stand for equal opportunities as an employer! We therefore look forward to receiving your application - regardless of age, gender, origin, sexual orientation, and religion.
Please apply in English.

Do you have any questions? Then get in touch with your contact person.

Mrs. Claudia Vignau

Visit our website Octapharma Career and follow us daily on LinkedIn .