Job title: Executive – Quality Assurance

Company: GlaxoSmithKline

Job description: Job Description : Site Name: India – Maharashtra – Nashik Site Posted Date: Jul 5 2022 Ready to help shape the future of healthcare? At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in

Job Description : Site Name: India – Maharashtra – Nashik Site Posted Date: Jul 5 2022 Ready to help shape the future of healthcare At GSK, we have already delivered unprecedented change over the past four years, improving R&D, becoming a leader in Consumer Healthcare, strengthening our leadership, and transforming our commercial execution. Now, we’re making the most significant changes we’ve made to our business in over 20 years. We’re on track to separate and create two new companies in 2022: New GSK with a leading portfolio of vaccines and specialty medicines as well as R&D based on immune system and genetics science and a new world-leading consumer healthcare company of loved and trusted brands. With new ambition comes new purpose. For New GSK, this is to unite science, talent, and technology to get ahead of disease together – all with the clear ambition of delivering human health impact stronger and more sustainable shareholder returns and as a new GSK where outstanding people thrive. Getting ahead means preventing disease as well as treating it. How we do all this is through our people and our culture. A culture that is ambitious for patients – so we deliver what matters better and faster accountable for impact – with clear ownership of goals and support to succeed and where we do the right thing. So, if you’re ready to improve the lives of billions, join us at this exciting moment in our journey. Join our challenge to get Ahead Together. Responsibilities- . The incumbent is accountable & responsible for Review of Batch documents & Batch release in accordance with GSK QMS & applicable regulatory requirements and acts as the first contact point for any Quality issues in area of operation. . Ensures compliance and inspection readiness . Ensures release of bulk and finished products, meeting the statutory and QMS requirements, to market . BMR, BPR and analytical reports review and subsequent compliance review, PPA – Trending and release for finished products with performing transactions in dMERP (SAP) system. . Handling of dMERP (SAP) system related to batch release and other QA transactions to enable batch release process is followed as per SOP with status tracking & communications. . Ensures that the manufacturing & packing operations on shop floor are in compliance with regulatory and QMS requirements . Ensures support provided for timely compliance to all audit observations in the area. . Reviews Master BMR / draft MFR of products manufactured and packed in area of operation as per regulatory requirements and SOPs. . Deviations/ Incidences in Dept. with Rapid Response, Participates in RCAs . Support L1, L2, L3 & L4 and conduct Self Inspections as per schedule . Ensures timely compliance to all audit observations in the area . Supports internal delivery performance. . Supports various validations on site. . Supports GPS roll out at site . Supports implementation of QIP for Quality department . Performs assigned Quality task as per requirement. . Demonstrates engagement to raise GEMBA Kaizen, to effectively utilize GPS tools as day-to-day ways of working. . Ensure that all risks for department are identified, assessed, and mitigated in accordance with risk management principles. To liaise with stakeholders like Manufacturing, Packing, QC, validation, Engineering and technical. Educational Qualifications- MSc/BPharm/MPharm Years of Experience- Minimum 3 years Type of Experience- Experience in Pharmaceutical QC/QA/Manufacturing. Optional experience- Experience in pharma testing/ Supervisory role is added advantage. Key Skills- Fluency in written and verbal communication Advanced computer operational/usage capabilities Expertise in data management and analysis. Team player with leadership, motivational and enabling skills Any Other Specifications- English, Hindi, Marathi At GSK we value diversity (Gender, LGBTQ +, PwD etc.) and treat all candidates equally. We aim to create an inclusive workplace where all employees feel engaged, supportive of one another, and know their work makes an important contribution. .LI-GSK Our goal is to be one of the world’s most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing. 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Expected salary:

Location: India

Job date: Thu, 07 Jul 2022 22:42:42 GMT

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