ESO QA Manager Biotechnology and Aseptics (m/f/d)
Area of Responsibility
ESO QA Manager Biotechnology and Aseptics, Schaftenau, Austria
Novartis is a global leader in generic and biosimilar medicines, committed to playing a leading role in driving access to medicine worldwide. For this mission, External Supply Operations (ESO) plays a key role. Join us and become a part of our dynamic and developing team!
Your responsibilities include, but not limited to:
• Act as single point of contact for all quality related activities at the external supplier.
• Lead the external supplier qualification process, including setup and maintenance of related core documents (e.g. quality assurance agreement, supplier quality risk assessment)
• Manage all quality aspects of the relationship in accordance with the effective Quality Agreement, the Novartis Quality Manual, relevant cGMP regulatory requirements and local SOPs. Including but not limited to the management of investigations (complaints, deviations, out of specification results, quality events), change controls, and regular quality reviews (e.g. annual product review)
• Oversee the technical release of batches manufactured at the CMO. Including but not limited to batch record review, incident review, and change review.
• Escalate any incident per Novartis escalation policy, and initiate any market action that is required
• Qualification as Qualified Person according to EU GMP Annex 16 could be a plus.
What you’ll bring to the role:
• University Degree in Biochemistry, Chemistry, Pharmacy, Microbiology, Biotechnology or equivalent
• English (fluent), German is a plus
• Minimum 5 years’ professional experience in the pharmaceutical industry
• At least 3 years within manufacturing of sterile pharmaceuticals
• At least 3 years’ experiences in operational QA
Why consider Novartis?
817 million. That’s how many lives our products touched in 2018. And while we’re proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people’s lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you’re given opportunities to explore the power of digital and data. Where you’re empowered to risk failure by taking smart risks, and where you’re surrounded by people who share your determination to tackle the world’s toughest medical challenges.
We offer a market-competitive base salary in line with your qualification, experience and individual competencies. Additionally we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning & development options and worldwide career opportunities within the Novartis group. The base pay is composed of a market oriented excess payment and the respective amount according to the Austrian collective agreement (at least € 48,718.04 per year on a full time basis)
We are Novartis. Join us and help us reimagine medicine.
Novartis are an equal opportunities employer and welcome applications from all suitably qualified persons.