Eso Sm Quality Assurance Manager
vor 1 Woche
ESO Quality Assurance Manager (d/f/m), Kundl, Tyrol, Austria
Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.
Now as an independently listed company, Sandoz aims to increase its strategic focus, operate with greater agility, set clearer business objectives, enhance shareholder returns, and strengthen its culture for us, the Sandoz associates.
This is an exciting time in our history, and by creating a new and ambitious path, it will provide a unique opportunity for us all, both professionally and personally.
Join us as a Founder of our 'new' SandozYour key responsibilities:
Please note that this is a temporary position with a fixed term of 2 years.
Your responsibilities include, but are not limited to:
- Acts as Single Point of Contact for all quality related activities at assigned external suppliers and provides the quality presence and input to technical meetings with the external suppliers.
- Ensures a valid Quality Agreement in line with the requirements of the Novartis global template is in place and continuously amended to the business needs. Ensures current external supplier quality risk assessments are in place and appropriate actions are taken to mitigate potential risks. Ensures site readiness for regulatory inspections and quality audits and supports during such events.
- Further ensures that change requests, either from the external supplier or from Sandoz, are managed appropriately from receipt, through to the implementation and closure
- Assesses quality trends and drives continuous improvement. Critically assess the performance of the product and processes performed at the external supplier. Escalates any issues or instances of instability as necessary.
- Implements and monitors Key Performance Indicators (KPI) and ensures that all parts of ESO are working in a consistent manner against harmonized expectations. Initiates corrective actions when necessary and performs followup on resulting measures.
- Manages all quality issues (complaints, deviations, OOX) and ensures investigations are correctly executed and all required actions are taken appropriately and in a timely fashion.
- Leads and supports all QA tasks required for new product launches and transfers and any other global initiatives with the scope of external manufacturers.
- We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
What you'll bring to the role:
Essential Requirements:
- Bachelor or higher in Biochemistry, Chemistry, Microbiology or another related science
- Min 5 years of experience in in the pharmaceutical industry. Good knowledge of the manufacturing of sterile pharmaceuticals.
- Min 3 years of experience in operational quality assurance. Advanced knowledge of cGMP requirements for major regulated markets (EU, US). Basic experience with FDA, EMEA and other Health Authorities. Advanced understanding of risk management. Basic understanding of project management.
- Excellent communication & negations skills with decisionmaking ability skills.
- Fluent in speaking / writing in English
Desirable requirements:
- Ability to work in a matrix organization
- German language is required.
Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more
With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.
**Imagine what you could do here at Sandoz
**In addition to a market-competitive base salary, we offer an attractive incentive program, a modern company pension scheme, childcare facilities, learning and development options as well as worldwide career opportunities.
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 € 60,212.18/year (on a full time basis).In most cases, the actual salary will be higher, as we strive to maintain a competitive position in the market and consider your previous experience, qualifications and individual competencies.
We are open for part-time and job sharing models and support flexible and remote working where possible.Commitment to Diversity & Inclusion:
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
- Division
- SANDOZ
- Business Unit
- Quality STO
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