Lead Expert Quality Assurance, Deputy Responsible Person 40%
Octapharma AG
Overview
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.
Act as the interface between Swissmedic and the Corporate Regulatory Department to organize new/maintain existing Marketing Authorisations of the products.
Fulfil required tasks in Pharmacovigilance as Deputy Local Drug Safety Officer for Switzerland/Liechtenstein.
Provide support in various Quality Assurance tasks (e.g., Document Management System, internal auditing, employee training, GxP tasks such as handling of change controls, deviations, CAPA, returns, PQR review, qualification of service providers).
Assume the activities and role of Responsible Person during their absence and when immediate action is required.
Ensure compliance with regulatory requirements (Swiss laws such as TPA, TPLRO, MPLO, GMP, GDP, and other relevant EU Guidelines) within the framework of the Establishment Licence authorised by Swissmedic.
Your expertise and ideal skill set
Pharmaceutical / life science background (Master). Preferably several years of experience in a role in the pharmaceutical industry, ideally within a Quality Unit. Experience in Regulatory Affairs and/or Pharmacovigilance is advantageous.
Excellent organisational skills, with the ability to manage multiple projects, a drive for excellence, and a positive "can do" attitude. Detail‑oriented, accurate, and confident in providing support when needed.
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, with corporate oversight tasks and responsibilities. Octapharma AG serves as the headquarters of the Octapharma group, operating in an international environment and maintaining contact with different affiliates worldwide.
You will support the Responsible Person, the Deputy Responsible Person, and the Associate Expert Quality Assurance Documentation in your role.
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.
Competitive, market‑related salary and benefits package.
High level of influence where you can make a difference and leave your footprint.
Work with skilled and fun colleagues in a relatively informal organisation.
Skills development – internal and external employee and leadership training, 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.
Want to find out more about us?
Visit our website
#J-18808-Ljbffr