Sr. Executive Quality Assurance

Job Description

With 64 manufacturing sites in 26 countries, our aspiration is to become the top manufacturer of innovative and generic medicines in the industry.Position Purpose:Highly skilled & experienced Quality professional who contributes by supporting of QMS & Oversite of GMP activities at Sandoz, Kalwe siteYour key responsibilities:Your responsibilities include, but are not limited to: Review of Equipment / System Qualification document (URS, DQ, IQ, OPQ etc.) Preparation, distribution, and monitoring of annual schedule for periodic review for need of re-qualification of equipment / system to all user departments. To archive and maintain qualification documents. Preparation. Review and / or approval of Failure Mode Effective Analysis (FMEA) & Quality Risk Assessment. Periodic overview of engineering & Admin Logbooks. Review and/ or approval of transport rout qualification document (SOP, transport qualification protocols and transport qualification reports) Review of calibration and preventive maintenance activities of manufacturing equipment. Review / Approve of SOP and Documents related to equipment / system qualification. QA oversight of engineering department, utility, service floor, calibration, and maintenance activities etc. To review / approve periodic review reports for need of re-qualification of equipment / system. Review and / or approval of track and trace project documents. To perform periodic user management of standalone and network system as an Administrator for laboratory instrument.EEO Statement Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.Minimum requirements What you ll bring to the role: B. Pharm/M. Pharm/M.Sc. from reputed institute 5-10 years, preferably in oral solid Dosage. Collaborating across boundaries Functional Breadth with min 3-5 years experience in Quality assurance of Pharma/Manufacturing sector such as analytical lab, Manufacturing, engineering in a GMP environment/equivalent. Qualification activities, Vendor management Investigation, QMS, Audit, Quality Control & Other GMP activities. Quality decision making, Knowledge of IT Applications & tools, Knowledge of TQM and related industry. GxP standards and processes.Why Sandoz 500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.How will we do this We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working. We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent whats possible, when we collaborate with courage to aggressively and ambitiously tackle the world s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!Imagine what you could do here at Sandoz!Commitment to Diversity & Inclusion: Novartis is committed to building an outstanding, inclusive work environment and diverse team s representative of the patients and communities we serve.Join our Novartis Group Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here: https://talentnetwork.novartis.com/network,

Keyskills :
quality controluser managementquality assurancevendor managementcareer opportunitiespreventive maintenancemaintenance activities