Lead Expert Quality Assurance, Deputy Responsible Person 40%
Job ID: 62135 Location:
Lachen, CH
Job Level: Professionals Job Category: Quality Employment Type: Permanent position Career Level:
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
1. Responsible for the compliance check of the batches intended for the Swiss market and for the administrative market release.
2. Acting as interface between Swissmedic and the Corporate Regulatory Department to organize new/maintain existing Marketing Authorizations of the products.
3. Fulfilling the required tasks in Pharmacovigilance as Deputy Local Drug Safety Officer for Switzerland/Liechtenstein.
4. 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.).
5. 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.
6. 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
7. 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.
8. 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.
9. 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
10. 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.
11. You will support in your role the Responsible Person, the deputy Responsible Person and the Associate Expert Quality Assurance Documentation.
12. This position is part-time (40 %).
Thrive with us
13. You help save lives - Every day is meaningful as we produce life-saving medicines
14. Family values - Long-term perspective for employees and relationships
15. Be rewarded with market-related salary and benefits package
16. You will have a high level of influence where you can make a difference and leave your footprint
17. Work with skilled and fun colleagues in a relatively informal organization
18. 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
Octapharma AG
Seidenstrasse 2, 8853 Lachen
T: +41 55 451 21 35
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About Octapharma
Octapharma is one of the largest human protein manufacturers in the world, developing and producing human proteins from human plasma and human cell lines. We employ more than 11,000 people worldwide to support the treatment of patients in 120 countries with products across three therapeutic areas: Immunotherapy, Haematology and Critical Care. With seven R&D sites and five state-of-the-art manufacturing facilities in Austria, France, Germany, and Sweden, Octapharma also operates over 195 plasma donation centres across Europe and the US. With four decades of experience, we are committed to advancing patient care worldwide.