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Company Name : Roche
Location : Mumbai, Maharashtra
Position : Local Quality Responsible
Job Description : Leads and oversees development, implementation, maintenance of and compliance with the Roche local quality system to assure full compliance, at all times, with Roche policies and procedures, governing legislation and regulatory requirements. Responsibilities may include managing a team of direct reports. Develops, implements and maintains the quality system for the local Roche business, which may include quality oversight, monitoring and reporting for clinical trial sites and other clinical study activities. Consults local leaders, functions, study management teams (SMTs) and others on quality and compliance matters. May also be responsible for the timely and compliant release of Roche products within the local market to support timely and compliant achievement of business plans and objectives. Stays abreast of internal and external developments, trends and other dynamics, as these potentially influence Roche’s pipeline and marketed products and other business interests. Manages local qualification in compliance with Roche policies and procedures, GxP and other governing legislation and regulatory requirements. Assesses impacts of evolving or changing regulatory standards and advises local leaders, functions and teams on any implications to local quality and compliance operations. Oversees approved updates to local quality system and associated standard operating procedures, relevant systems and processes and ensures appropriate communication and education for local functions and teams. Leads or otherwise assists with implementing local corrective and preventative actions (CAPAs). May select, develop, and evaluate employees to ensure the efficient operation of the function.
Who we are
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Roche is an Equal Opportunity Employer.
Job Level:
Individual contributor
This post is listed Under Mumbai jobs
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