Novartis Hiring For R&D Quality Manager
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Novartis Hiring For R&D Quality Manager |
Position: R&D Quality Manager
Summary
Independent Project work less complexity, e.g. early phase projects. Lead or support smaller and less complex projects or support more complex projects with mentoring. Higher complex routine tasks e.g. failure investigations and deviation, change controls etc. Manage projects and processes to support departmental portfolio, projects and objectives according to agreed timelines and standards. Ensure that compliance with cGMP is maintained in TRD.
About the Role
Key Responsibilities
- Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibility
- Write review, decide on approval and/or release of GMP-relevant deliverables and/or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
- Manage project related activities (e.g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility.
- Support Project management functions as a project team member.
- Provide support to TRD line functions in GMP related topics as per area of responsibility.
- Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance, SOPs etc.).
Minimum Requirements:
- Masters, Bachelor/Technician (> 5 years’ pharma)
- Fluent English required (oral & written) Good skills in site (local) language desired.
- Good knowledge of cGMP, working knowledge in technical development, production or QA.
- Sound scientific, technical and regulatory knowledge.
- Good organizational and decision-making skills.
- Good and proven ability to analyze and evaluate cGMP compliance.
Apply Now
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