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4 Quality Requirements Jobs

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3.0 - 7.0 years

0 Lacs

maharashtra

On-site

You will be responsible for coordinating and overseeing the labelling process (Label Change Request LCR) across multiple departments, including the Labelling Team, Supply Chain, internal and external plants, and Local Regulatory Affairs. Your primary focus will be to ensure compliance with regulatory and quality requirements/standards, manage manufacturing and logistic constraints, and implement timely packaging material changes to minimize costs and reduce write-offs. Your core responsibilities will include coordinating labelling activities for New Product Introduction in collaboration with Launch Managers to ensure timely product launches. You will also be responsible for ensuring the on-time execution of Label Change Requests (LCR) by aligning regulatory and quality requirements, technical specifications, and implementation dates. It will be crucial to guarantee that LCR implementation does not adversely affect other affiliates sharing the same products or packaging. You will lead efforts to analyze and resolve bottlenecks in the labelling process, facilitating effective communication and collaboration among stakeholders to ensure smooth and efficient operations. Conducting regular performance reviews with stakeholders to evaluate KPIs, monitor priorities, and identify continuous improvement opportunities in the labelling process will also be part of your responsibilities. Ensuring quality and regulatory compliance of labelling activities and processes in accordance with departmental procedures and applicable Abbott policies will be essential. You will also manage documentation by creating and maintaining Work Instructions and Standard Operating Procedures related to the labelling process. Additionally, you will develop and provide training for Labelling Team personnel and other stakeholders involved in the labelling processes. In terms of supervisory/management responsibilities, you will not have any direct or indirect reports. The minimum education requirement for this role is a bachelor's degree, preferably in a scientific or business discipline or equivalent. You should have a minimum of 3 years of experience in the Life Sciences business (Operations, Regulatory, Quality) and proficiency in business systems and tools, including Artwork Management System, Enterprise Resources Planning, Project & Portfolio Management solutions. Demonstrated expertise and training in GMP/GxP standards for pharmaceutical products are also required. Desired skills/experiences include exposure to international markets, excellent verbal and written communication skills in English, including presentation skills, the ability to work effectively within a complex organization, and collaborate with diverse stakeholders. Strong discipline and stress resilience, with proven experience in managing and delivering multiple tasks on time, high accuracy and attention to detail, with an understanding of the consequences of poor data quality, and strong project management skills, including issue identification, problem analysis, and solution development, are also desirable for this role.,

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3.0 - 7.0 years

0 Lacs

chennai, tamil nadu

On-site

Choosing Capgemini means choosing a company where you will be empowered to shape your career in the way you'd like, where you'll be supported and inspired by a collaborative community of colleagues around the world, and where you'll be able to reimagine what's possible. Join us and help the world's leading organizations unlock the value of technology and build a more sustainable, more inclusive world. In this role, you will play a key role in processing routine PR-PO, which involves reviewing Purchase Requisitions for compliance and releasing completed Purchase Orders for approval. You will also be responsible for monitoring the preparation of purchase orders in line with final negotiations with selected suppliers and in accordance with organizational targets, requirements, as well as client quality requirements. What you love about working here: - You can shape your career with us. We offer a range of career paths and internal opportunities within the Capgemini group. - You will also receive personalized career guidance from our leaders. - Comprehensive wellness benefits are provided, including health checks, telemedicine, insurance with top-ups, elder care, partner coverage, or new parent support via flexible work. Capgemini is a global business and technology transformation partner that helps organizations accelerate their dual transition to a digital and sustainable world, creating tangible impact for enterprises and society. With a strong over 55-year heritage, Capgemini is trusted by its clients to unlock the value of technology to address the entire breadth of their business needs. The company delivers end-to-end services and solutions leveraging strengths from strategy and design to engineering, all fueled by its market-leading capabilities in AI, generative AI, cloud and data, combined with its deep industry expertise and partner ecosystem.,

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12.0 - 16.0 years

0 Lacs

indore, madhya pradesh

On-site

You will be responsible for leading and driving sales, marketing, and business development initiatives in the fermentation-based Active Pharmaceutical Ingredient (API) segment as a Sr. Manager / AGM / DGM API Fermentation. Your role will entail developing and executing sales and marketing strategies for fermentation-based APIs in both domestic and international markets. You will need to build and manage client relationships across pharma companies, CMOs, and regulatory markets, while also identifying new business opportunities and expanding the customer base. Collaboration with R&D, production, and regulatory teams will be crucial to align business goals with technical capabilities. You will also need to have a deep understanding of regulatory and quality requirements for fermentation-based APIs across different geographies. Participation in industry events, exhibitions, and customer meetings to promote products and services will be part of your responsibilities. Additionally, you will be expected to prepare sales forecasts, reports, and performance metrics for management review, manage contract negotiations, pricing strategies, and commercial terms, and maintain a thorough understanding of fermentation technologies and market trends. To qualify for this position, you should hold a Bachelors or Masters degree in Life Sciences, Biotechnology, Microbiology, Chemical Engineering, Pharma, or a related discipline. You must have 12 to 15 years of relevant experience in sales, marketing, or business development of fermentation-based APIs, with strong technical exposure to classical fermentation processes and products. An excellent network and knowledge of the API/pharma ecosystem in India and globally is essential, along with strong communication, negotiation, and presentation skills. A willingness to travel as per business requirements is also required. Preferred skills for this role include experience in handling regulated markets such as USFDA, EU-GMP, knowledge of downstream processing and strain development, as well as strong analytical and commercial acumen.,

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8.0 - 12.0 years

0 Lacs

chennai, tamil nadu

On-site

Designation: Manager Civil Engineering Design & Project Management (Wind Turbine Civil Foundation) Experience: 8 to 10 Years in the Wind Turbine Industry preferably in both Design and Project Field Experience. Educational Qualification: BE Civil Engineering / Structural Engineering Educational Qualification: BE Civil Engineering / Structural Engineering Key Responsibilities: Review of Soil analysis, load-bearing capacity, and geotechnical assessments. Capable to perform Civil Foundation Design and Anchor Cage Design Verification of Drawings of Civil Foundations & Structural Design. Preparation of Bar Bending Schedule Interaction with Customer, Consultant and Project Execution Team Finalise the Quality Requirements to prepare the Civil Foundation Manual and QAP. Need based visit to Site to establish the Drawing Requirements by Training and Monitoring. Capable to Trouble Shooting and Re-engineering of the Civil Foundation.,

Posted 1 week ago

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