Responsible for the preparation of the Annual Stability Report and Annual Product Review Report for Novartis marketed products and select third party products, per contractual agreement, in accordance with company and government regulations.
Major Accountabilities (Describe the principal outcomes of the role)
Bachelor of Science degree in a scientific discipline.
- Responsible for the preparation of the Annual Stability Reports according to the established schedule.
- Responsible for the preparation of the Annual Product Review Report according to the established schedule.
- Responsible for the compilation and data interpretation of analytical, manufacturing and regulatory data.
- Responsible to draw conclusions from real-time data and statistical reports.(if available)
- Responsible to ensure that established testing control procedures are followed.
- Responsible for providing Annual Stability Reports to Drug Regulatory Affairs for timely submission to the Federal Drug Administration.
- Responsible for providing stability data and reports for product related evaluations, e.g., compliance investigations, divestitures, product transfers, validation, etc.
- Responsible for managing data and instructing others in the Annual Stability Report writing function.
- Responsible for serving on various project teams to fulfill activities as assigned.
- Responsible for writing and updating applicable SOP’s
- Responsible for maintaining ASR/APR schedule.
- Responsible for the Annual Stability Reports and Annual Product Review Report record keeping.
- Responsible for the scheduling meetings with the APR Team to determine and assign follow-up action items. Minimum requirements Education:
Minimum 5 years in the pharmaceutical industry with an emphasis on Quality Assurance.
Demonstrated cGMP knowledge. Applicable PC software knowledge and prior experience with Dragon, ETDI, SAP, MES, LIMS (Laboratory Information Management) ERP systems. Possess the ability to manage multiple tasks and work independently in ambiguous situations. Excellent technical writing skills, file organization, and the ability to manage data is required. Strong analytical background.
Knowledge of stability regulation and its application to the industry.
Knowledge of cGMPs. ( ICH Guidelines)
Excellent organizational and communication skills.
Excellent interpersonal skills including use of tact, diplomacy, discretion and judgement.
Novartis - 2 years ago
Novartis AG, incorporated on February 29, 1996, is a Switzerland-based holding that, through its subsidiaries, is engaged in the research,...