Qualified Person (QP) for Biopharmaceuticals (m/f)

Job description

Job Description

Release of biopharmaceutical drug products produced on site and at Contract Manufacturing Organizations
• Review and approve master batch manufacturing records as well as Annual Product Quality Reviews
• Participation in investigation on critical complaints, OOS/OOT, recalls and escalations
• Review quality agreements, change controls and process validation protocols
• Participation in the execution of risk assessments, audits and inspections
• Implementation of GMP training courses

Desired profile

Minimum requirements

• Education: University Degree in the natural sciences (ideally pharmacy, or biochemistry, biology, microbiology or equivalent)
• Languages: fluent in English and German is beneficial
• Experience: Minimum 4 years of QA experience, ideally in the release of sterile pharmaceutical products and 2 years of experience in QC (required for QP certification in Austria), experience in biopharmaceuticals is beneficial.

We are offering a competitive salary in line with the market and based on your qualification, experience and individual competencies. Additionally we are offering an attractive Bonus/Incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group. The basic salary is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least EUR 75,000 per year).

Contact: Cornelia Walch, Staffing Manager