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 8e.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:
Work Experience:
* 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)
Skills Desired