Our team is seeking a highly skilled QA Operations Expert to support the development and implementation of quality control procedures. In this role, you will have the opportunity to collaborate with cross-functional teams to identify and mitigate risks, and to develop your skills in areas such as GxP functions, regulatory compliance, and quality assurance agreements.
About the Role
This is a part-time position, requiring 50% employment. Your responsibilities will include, but are not limited to:
* Oversight of GxP functions across the site to ensure product quality.
* Implementation, compliance with, and governance of practices prescribed in the Manufacturing Manual.
* Acting as release responsible person;
ensuring regulatory compliance and implementation of corporate quality standards and regulations.
* Review and approval of PQR/APQR;
ensuring exception (deviation and OOX) and complaint management and investigation, as well as proper definition and implementation of CAPAs.
* Evaluation and compliance with all cGxP and all regulatory requirements for manufacturing, control, and distribution operations;
adherence to HSE guidelines and requirements.
* Collaboration in internal and external audits;
ensuring any collaborations with third parties are performed with adequate Quality Assurance Agreements in place.
Requirements
To succeed in this role, you will need:
* A University Degree in Pharmacy, Biochemistry, Biotechnology, Chemistry, Microbiology, or equivalent.
* Professional experience in the pharmaceutical industry, with direct experience with Pharmaceuticals, Biopharmaceuticals, or API products and at least 2 years within QA, thorough knowledge of cGMP requirements, as well as a proven track record with FDA/EMA and other Health Authorities.
* Knowledge of GMP and Management of Quality Audits.
* Flexibility to work in a fast-paced, quickly changing work environment.
* Knowledge of Manufacturing Process/Product Expertise.
* Fluent knowledge of English and German (written and spoken).
Benefits
We offer a competitive salary, an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development opportunities, as well as worldwide career possibilities within our organization. In accordance with Austrian law, we are obliged to disclose the minimum salary as stated in the collective bargaining agreement. For this position, the minimum salary is €65,605.54/year (on a full-time basis). The actual salary will be significantly higher, considering your previous experience, qualifications, and individual competencies.