QA Specialist At Novartis
Job Description
As a Quality Assurance Specialist you will be responsible for the technical and market release (QP) after assuring that appropriate practices, systems and processes are in place working closely with the Quality Control (QC) teams, by executing QA oversight; assuring that all QC areas and relevant activities are following the requirements of ISO9001, HAs, cGMP, GLP and Novartis Quality Management System (QMS), and that quality strategy is implemented with a continuous drive to improve products, practices and processes quality.
This role reports directly into the QA Operations Head and will work hand in hand with the Quality Teams.
Key Responsibilities:
• Quality records QA and final QA decision maker for all quality records including deviations and release OOS/OOE records related to FGs, stability and different QC lab areas.
• Review/ approval of QC GxP documents and records.
• Delegated release person from site Quality head (i.e. QP) to ensure QC results completion and being reviewed by qualified QC reviewer and for “Duty of care check”.
• Execution of planned and unplanned QA oversight activities in QC and Microbiology areas to ensure the ongoing compliance status, that QMS requirements are followed and in place, to identify areas of improvement, agree upon needed actions (e.g. CAPAs) based on outcomes and follow-up appropriate closure of the outcomes.
• A certified investigator that supports in QA investigations of quality records (e.g. Deviations, complaints, etc.) and QC OOS/OOE records.
• Overseeing reference standards handling process and approving the in-house qualification reports and certificates of analysis, and releasing of the reference standard batches for use.
• Supports in all QC operations QA tasks related to AS&T (Stability, Validation, and Qualification) whenever requested or delegated.
• Perform all site-support tasks whenever requested.
• Deputize QC/QA Operations Expert (QC, Microbiology & Release QA) whenever delegated.
Essential Requirements:
• Bachelor’s degree in Pharmaceutical Science or a relevant discipline.
• 0-2 years of experience in a relevant position.
• Fluency in English and Arabic Languages.