Executive Quality Control - Chemical

Job Description

Novartis Technical Operations (NTO) brings billions of units of medicine to countries around the world. Your responsibility includes, but not limited to:Highly skilled & experienced laboratory professional who contributes by performing analytical release testing, investigational support, research support, and stability testing.OOx/Deviation handling . CAPA definition -KPI trending Ensure all activities in compliance with cGxP, incl. data integrity review and approval of analytical data / tests (analytical release) Stability -Stability testing (Projects) protocol preparation, evaluation, report preparation . Reporting (Stability plan preparation, trend analysis, evaluation). Performance of Stability studies, protocols and comparative reports for supplier qualification. Review and approval of analytical tests (analytical release). Microbiological QC Perform Microbiological testing of materials and utilities, environmental & personnel monitoring, Provide expert Support for site qualification & validation activities. Maintain and calibrate equipment incl. plan preparation -Support in supplier qualification. Trending and analysis of KPI/KQI. Support sample planning and sampling execution. To Prepare, Sterilize and dispense media and carry out growth promotion test. Microbiologist should have exposure to handling of oncology product like drug substance and drug products. To carry out Steam Sterilization Cycle. To perform analysis of registration batches for the drug substance, excipients & drug product for microbiological tests. To perform sampling of water, compressed gas systems and HVAC system (Environment monitoring). To Perform Environment Monitoring, Gowning qualification of Controlled areas in Microbiology laboratory and in Production Areas. Maintain Microbial Cultures, To perform testing of Biological Indicator. To perform internal calibration of instruments. Monitor cleaning and waste disposal of Oncology molecules for microbiology laboratory. To review instrument /Equipment annual maintenance contract and coordinate with external party for validation and calibration activities. Accountable for safe operation of the facility, their own safety and safety of other co-workers. Follow Good Documentation Practices (GDP) and Good laboratory practice (GLP). Knowledge of Quality Management systems. Have knowledge about destruction/decomposition of Oncology product.Timely submission of documents pertaining to day-to-day analysis to reviewer. Ensure safe working conditions as per guidelines issued by HSE department. Follow standard operating procedure of Quality control & analysis. Ensure Data integrity, cGMP, GDP, ALCOA and ALCO.The relevant KPIs that are defined in the Quality Control areas apply: e.g. analytical lead times -Timely and GMP-compliant analysis & documentation of the results. Error rate: Number of OOS (analysis errors) related to the number of analyzes. No complaints about official inspections. Individual performance is assessed using the PMP performance dialog together with the manager.Operational Excellence Organizational Savvy Being resilient Breakthrough Analysis. Minimum requirements Skills : Collaborating across boundaries Functional Breadth 3-5years experience in Pharma/Manufacturing sector in analytical lab in a GMP environment/equivalent English Laboratory Excellence Laboratory equipment Quality Control (QC) Testing Quality Control Sampling Quality decision making Knowledge of IT Applications & tools Knowledge of TQM and related industry GxP standards and processes.3-7 years, specifically in Oncology Microbiology Lab at Oncology Cite Collaborating across boundaries Functional Breadth Executive - 3-5years experience in Pharma/Manufacturing sector in analytical lab in a GMP environment/equivalent.Education : BSc, MSc Microbiology.Commitment to Diversity & Inclusion:Novartis embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network.Why consider Sandoz Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks. Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics. Join us, and help reimagine access to medicine.,

Keyskills :
trend analysiswaste disposalstability studiesmusic makingdocumentationhplccalibrationstandard operating procedurehvac systemdata integrityquality managementquality controlisoreport preparation