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.
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
Benefits of Working
Performance based annual bonus
30 working days’ holiday per calendar year
Subsidised on-site cafeteria
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)
Quality Assurance Manufacturing Customer Service
Tagged as: ESO QA Compliance Expert (m/f)
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