Job Description Summary
Location: Basel Switzerland #onsite
Role Purpose: Manage independently technical development projects and related processes to support departmental portfolio projects and objectives according to agreed timelines and standards within Technical Research & Development (TRD).
Job Description
Major accountabilities
* Manage project related activities e.g. TRD product portfolio processes quality initiatives Quality risk Assessment as per area of responsibility
* Support Project management functions as a project team member
* Provide Quality Oversight and 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.)
* Release of batches materials and components for clinical trials with issuance of batch certificates and approval of development documentation
* Review of master and executed batch record
* Write review and complete GMP relevant documents (e.g. CoAs BRR checklists risk assessments)
* Support audits and inspections
* Can act as QA SPOC for assigned CMOs
Key performance indicators
* In accordance with departmental objectives such as support of projects with agreed quality and delivery dates passing of internal and external inspections
* Maintain sound working relationship with internal customers and external partners
* Meet quality and timelines in area of responsibility
* Feedback from team members
* Act in accordance with Novartis standards in particular: cGMP ethical health safety and environment (HSE) and information security (ISEC)
Minimum Requirements
* Masters
* Bachelor/Technician (>5 years pharma)
* Critical Negotiations.
* Project Management.
* Collaborating across boundaries.
Skills
* Oligo manufacturing and analytics highly desired
* Sterile manufacturing highly desired
* Good knowledge of cGMP working knowledge in technical development production or QA
* Good organizational and decision-making skills
* Good and proven ability to analyze and evaluate cGMP compliance
* Agility
* Continuous Learning
* Influencing Skills.
Languages
* Fluent English required (oral & written)
* Good skills in site (German) desired (oral)
Required Experience
Manager
Key Skills
* Continuous Integration
* Quality Assurance
* FDA Regulations
* Root cause Analysis
* TFS
* Food Processing
* ICH Q10
* Jira
* Software Testing
* Quality Management
* Selenium
* Github
Employment Type
Full-Time
Vacancy
1
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