The position will be responsible for QA tasks with a primary focus on compilation of APR and MCSR submission, tracking, trending and evaluation of APR and Stability data, along with respon-sible for Quality Assurance (QA) oversight activities with contractors manufacturing, testing, pack-aging, distributing and/or holding for those products which he/she is responsible, providing guid-ance to ensure compliance with Novartis, regulatory authority requirements and current Good Manufacturing Practice (cGMP).
Engage in various QA responsibilities with contractors, such as in the review and approval of master and executed batch records, validation protocols and final reports for process and analytical activities, investigation reports, stability commitments, Manufacturing Changes and Stability Report (MCSR), Annual Product Review (APR) and Chemistry, Manufacturing and Control document (CMC) submissions, etc.
Oversee contract manufacturers, providing guidance from a QA perspective, to ensure compliance with Novartis and regulatory authority requirements/cGMP for such activities as change management, cleaning/process/equipment/method validations, process opti-mization, scale-up and registration batch manufacture, effectiveness of corrective and preventive actions (CAPA) for investigations, deviations and complaint handling.
Evaluate trends periodically for key process indicators, such as customer complaints, de-viations, out of specification (OOS) investigations, stability, CAPA, etc. to ensure systems are functioning in compliance with Novartis and regulatory authority requirements/cGMP; implement appropriate actions where necessary.
Support site initiatives related to quality systems and trending of quality metrics for track-ing stability testing, customer complaints, stability OOS, and APRs.
Maintain, develop and/or revise existing Quality Systems standard operating procedures (SOPs) for Stability, MCSR, APR and Product defect complaints.
Provide support for OOS, deviations, and change controls as necessary. Minimum requirements Bachelor’s degree in a scientific discipline or 3-5 equivalent experience in Quality Assurance/control experience preference in an Animal Laboratory environment
1-3 years experience in chemical/pharmaceutical development or manufacturing compliance monitoring.
Knowledge and experience with statistical tools
Knowledge of analytical chemistry and statistical quality control.
Knowledge of Good Manufacturing Practices (GMP)
Previous experience in the review and approval of manufacturing batch records or related documentation for cGMP compliance is highly desirable.
Knowledge of PC package tools, including but not limited to: word-processing (Word), Spreadsheets (Excel), and (PowerPoint). Presentations.
Knowledge of the Laboratory Information Systems (Lims) and trackwise software system is desirable.
Knowledgeable with computer system regulations (21 CFR Part 11 & Validation) is desirable.
Experience with validation of both Laboratory instruments and their associated compliance issues.
Ability to set priorities and manage multiple tasks and meet deadlines. Ability to effectively communicate verbally and in writing.
Effective interpersonal skills.
Ability to submit accurate and appropriate data.
Strong project management skills and able to handle multiple priorities simultaneously.
