ESO QA Compliance Expert (m/f)

Novartis Technical Operations
Division Novartis Technical Operations
Geschäftseinheit NTO QUALITY
Standort Holzkirchen (near Munich)
Funktionsbereich Quality
Art der Stelle Vollzeit
Anstellungsverhältnis Regular
StellenID 246156BR


Stellenbeschreibung

Job Summary

Would you like to work for a Global Generics and Biosimilars company and contribute to our mission to extend and improve people’s lives?

Look no further, apply today. ESO QA Compliance Expert (m/f), Sandoz, Holzkirchen (near Munich), Germany.

Sandoz is currently recruiting for a ESO QA Compliance Expert (m/f) to develop, implement and continuously improve the QA processes and procedures for the external supplier operations.

Job purpose

The purpose of this role is being responsible for the development, implementation and continuous improvement of the ESO QA processes and procedures within Novartis Technical Operations and for providing Quality Oversight of external suppliers providing APIs, drug products and materials according to cGMP/ICH, Regulatory Authority and Novartis Group Quality Manual requirements and Policies.

Key Responsibilities

• Support the QM /GOP /SOP implementation and Harmonization within NTO ESO.
• Participation in the development, implementation and continuous improvement of NTO ESO QA processes, procedures and standards to ensure compliance with Novartis Quality Modules and Directives related to Supplier management
• Development of ESO Quality management business processes and Support the all ESO organization providing Compliance Standards or guidelines
• Standard Operating Procedures management defining business processes for managing Suppliers in the scope of ESO and monitoring performance against Novartis Quality Standards
• Drive improvement projects across ESO QA organization as needed
• Maintain current knowledge of local and international regulatory and legislative requirements and trends.
• Interact with main stakeholders within ESO Platforms/Regions to improve the quality and compliance for ESO supplier management
• Participate in the reporting on Global ESO Quality activities and Risk Assessments, and manage defined Key Quality Indicators (KQIs)
• Support NTO ESO readiness for Internal Audits
• Provide specific required trainings for NTO ESO and support on Network communications



Quality


Mindestanforderungen

About Sandoz

Sandoz is a global leader in generic pharmaceuticals and biosimilars. As a division of the Novartis Group, our purpose is to discover new ways to improve and extend people’s lives. We contribute to society’s ability to support growing healthcare needs by pioneering novel approaches to help people around the world access high-quality medicine. Our portfolio of approximately 1000 molecules, covering all major therapeutic areas, accounted for 2017 sales of USD 10.1 billion. In 2017, our products reached well over 500 million patients. Sandoz is headquartered in Holzkirchen, in Germany’s Greater Munich area.

Benefits of Working for Sandoz

• Competitive salary
• Performance based annual bonus
• Work/life integration
• Eligible to Sandoz pension plan
• 30 working days' holiday per calendar year
• Subsidised on-site cafeteria
• Free shuttle bus between Sandoz and Holzkirchen train station
• Additional benefits

‘I came for the job, I stay for the culture’


The ideal candidate will have

• Bachelor or higher degree in Pharmacy, Biochemistry, Chemistry, Microbiology or another related science
• At least 5 years experience in quality areas, quality assurance, GMP, compliance, within either pharmaceutical or chemical industry (for pharmaceutical purpose)
• Onsite experience in supplier management, production and/or other quality assurance positions
• Thorough knowledge of cGMP requirements
• Strong technical understanding of pharmaceutical environment processes and regulatory requirements for commercial products
• Proven track record with FDA, EMEA and other Health Authorities
• Strong understanding of risk assessment and risk management fundamentals/tools
• Team and consensus builder, with definitive and authoritative decision making ability and experience in international matrix organizations
• Good communication and solid analytical skills, comfortable with metrics and data management, a good reviewer
• Fluent in written and spoken English, 2nd language desirable but not mandatory (e.g. German)


We focus on creating an inclusive organisation and welcome people who have different knowledge, perspectives, experience and working styles from across the global population.



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