QA Lead Aseptics (m/f/d)
Area of Responsibility
QA Lead Aseptics (m/f/d), 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, ESO QA Europe Steriles plays a key role. Join us and become a part of our dynamic and developing team!
Your responsibilities include, but are not limited to:
• Ensure that all aspects of the manufacturing of sterile products for Novartis at identified CMOs and Suppliers locacted in Europe comply with the requirements of the Novartis Quality Manual and Policies and meet all relevant cGMP, regulatory and legislative requirements.
• Provide leadership, direction and support to third parties (both local and global suppliers) and ensure that they are qualified, achieve a high level of competence and are motivated to carry out their duties in a safe manner. This includes regular site visits to local suppliers.
• Lead External Supplier’s Qualification process in conjunction with the QAM and ensure that QAMs are meeting requirements associated with Quality Agreements, audit plans, supplier qualifications, Batch Record Qualification and change control.
• Maintain current knowledge of local and international regulatory and legislative requirements and trends to ensure that technical support on all quality related matters is provided to the third parties.
• Lead site readiness for regulatory inspections at External suppliers where appropriate and lead site remediation from regulatory inspections.
• Review all Critical Quality Issues (deviations, complaints, recalls, counterfeits and product tampering, stability failures, etc.) in conjunction with the QAM according to the Quality Assurance Agreement and the Novartis Quality Manual.
• Responsible for assessing Quality trends and leading Continuous improvement for processes and product quality performance across external suppliers.
• Escalate all potential quality issues as per the Novartis escalation policy and to higher level management, especially the ESO QA Head Europe Steriles, and initiate all actions as defined.
What you’ll bring to the role:
• Higher university degree (e.g. MS or Ph.D.) in Biochemistry, Chemistry, microbiology or another related science
• Fluent in English
• 10-15 years working experiences in a GMP environment like QA operations, pharma production, R&D, QC ideally in aseptic processing and/or other related area mandatory
Why consider Novartis?
750 million. That’s how many lives our products touch. 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 €70.879,62 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.