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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.,
Posted 2 days ago
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