Quality System and Compliance Specialist

Quality System and Compliance Specialist 

STADA is a leading manufacturer of high-quality pharmaceuticals. With a long-standing heritage rooted in pharmacies, we are perceived as a reliable and trustworthy partner since 1895. With our products we help people protect and regain a dignified and able life. With our proven Generics, we ensure that everyday health remains affordable.

At STADA, we follow our purpose of “Caring for People’s Health as a Trusted Partner”. In pursuit of this purpose, we are committed to further accelerating the successful trajectory of our company.

To our employees, we offer an attractive working environment in which they can develop personally.

Responsabilities:

• Implementation of the quality system within the company, as well as monitoring its efficiency in order to maintain and constantly improve the system.

• Management of documentation systems, review and approval of the documents.

• Personnel training with the good documentation practices and Data Integrity principles.
• Implementation of quality systems and quality processes in accordance with GMP requirements (Good Manufacturing Practice).
• Management of Quality Issues and Incidents, Quality Events and Deviations, not related with finished products.
• Involvement in the Validation Master Plan and Report documents’ lifecycle (issuance, review and approval).
• Revision and approval of the equipment qualification.
• Monitoring and approval of Corrective and Preventive Actions (CAPA) (e.g. established after a quality incident, deviations, self-inspections)
• Supplier management process: qualification, monitoring, identification of audit needs and planning and supplier exit process.
• Involvement in Self-inspection and Quality Walkthroughs process.
• Inspections/Audits readiness and management
• Quality Technical Agreement
• Quality objectives achievement with regards to Quality Systems and Compliance activity and involvement in Quality Excellence projects.

If you are ready for new challenges where you can make a difference for people’s health, you have come to the right place. We are looking for people with great attitude and passion. The next step is yours, take a look at our open positions and become part of our global STADA team!

Please note that only successful candidates will be contacted.