The Quality Operations Partner, AS&T; Expert is responsible for managing all analytical aspects within responsible projects to ensure that the operational business is in compliance with cGMP (Current Good Manufacturing Practices), the Quality Assurance Agreement, regulatory requirements & the Novartis Quality Manual and is conducted according to the relevant Standard Operating Procedures. Ensures analytical Life Cycle Management for commercial products and ensures timely analytical implementation for recent projects.
Job Description
Major accountabilities:
- Management and oversight of all analytical activities related within responsible projects.
- Perform activities related to equipment qualifications and computer system validations.
- Support ELN building or master building activities for LIMS.
- Life-cycle management of analytical methods, including control of method performance, analytical method improvements, pharmacopoeia and health authority compliance (subject matter expert in health authority inspections)
- Single point of contact for internal and external clients and contract laboratories, if applicable.
- Ensure timely analytical implementation (Method Transfer and Method Validation) for (new) projects in the course of product transfers.
- Scientific analytical support for quality control, production, registration and marketing.
- Setup and monitoring of stability studies.
- Support overarching product investigations cross functional, e.g. QC, QA, Production, MS&T.;
- Implementation of GMP requirements. Compilation and review of documents (analytical protocols and reports, annual performance quality reports, ongoing process verification reports, registration documents).
Essential Requirements:
- Education: M.Pharm/ MBA / M.Tech/MSc/Engineering/equivalent from a reputed institute.
- Minimum 8 years’ experience in Quality Assurance, Quality Control, AS&T;, Regulatory or in the manufacturing of pharmaceutical drug substances or product