2 Deviation Investigations Jobs

Regeneron is founded on the belief that the right idea, combined with the right team, can lead to significant transformations. Our growing global network is dedicated to inventing, developing, and commercializing medicines that change lives for those with serious diseases. In doing so, we are pioneering innovative approaches to science, manufacturing, and commercialization, as well as redefining our understanding of health. We are seeking a dedicated professional to manage a team of Global Procurement Compliance Managers and Specialists responsible for ensuring adherence to all cGMP compliance aspects within procurement operations. This role will involve leading all aspects of critical compliance activities, including deviation investigations, CAPAs, supplier audit management, change controls, and the development and implementation of the Supplier Corrective Action Report (SCAR) management process. A Typical Day Might Include The Following Monitor, report, and respond to Key Performance Indicators (KPIs) for compliance functions, such as Right-First-Time (RFT) performance in deviation investigations. Support the integration and start-up of Global Procurement compliance functions in Bangalore, collaborating closely with compliance teams across IOPS locations Analyze enterprise cybersecurity policies and configurations to evaluate compliance with regulations and enterprise policies and standards. Maintain the Approved Supplier List (ASL) and conduct periodic reviews of suppliers. Drive successful supplier audit closures by proactively resolving issues, maintaining clear communication with suppliers, and ensuring evidence collection for audit closure related to raw materials and components. Provide mentorship and guidance on performance and career development to direct reports, if applicable, and demonstrate leadership to inspire the organization. This Job Might Be For You If You Bachelors degree in a relevant field and dynamic experience in procurement, preferably within a Pharma/BioPharma or cGMP environment. Seeking a seasoned professional with over 12+ years of experience in quality compliance. Proven track record to lead continuous improvement initiatives and build influential relationships with stakeholders and suppliers to get results. Proven ability to operate with integrity, focus, and visibility in ambiguous environments while leading change and improvement. Experience in handling and developing associate-level professionals in a multinational organization, including performance reviews, setting objectives, and mentor. Proficient in standard business applications such as MS Word, Excel, and PowerPoint for communication, presentation, and analysis Driving successful audit closures by proactively resolving issues, maintaining effective communication with suppliers, and collecting evidence for audit closures related to raw materials and components. Providing coaching and guidance to direct reports on job performance and career development, where applicable, while setting a strong leadership example within the organization. Connect with us, so we can learn more about you, and you can learn more about our medicines. And join us in crafting the future of healthcare. Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need. Does this sound like you Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels! Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company&aposs business. For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location. Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc. Show more Show less

As a Manager - Corporate Quality Audit at Sun Pharmaceutical Industries Ltd, you will be responsible for overseeing the Gamma Irradiation of Sun Pharma products at third-party gamma irradiation sterilization sites. Your primary role will involve supervising the sterilization process, monitoring the irradiation of batches, and ensuring compliance with quality assurance regulations and auditing techniques. Key responsibilities include: - Demonstrating a sound understanding of pharmaceutical manufacturing processes for both non-sterile and sterile formulations. - Supervising the Gamma sterilization site used for sterilizing drug products and components. - Monitoring the receipt and dispatch of Sun Pharma consignments at the sterilization site. - Reviewing and analyzing irradiation processes and related documentation. - Controlling and monitoring quality systems to ensure compliance with cGMPs. - Participating in investigations for deviations, OOS, and audit findings related to Sun Pharma products. - Reviewing changes in the sterilization process and promptly notifying management. - Assisting in external audit preparations and responding to audit findings. To excel in this role, you should have: - A Bachelor's degree in Pharmacy or a Master's degree in Science. - 10-15 years of industrial experience in formulation and quality systems management. - Exposure to regulatory agency audits such as USFDA, MHRA, ANVISA, TGA, WHO, and ISO. - Familiarity with Trackwise, LIMS, and SAP systems is desirable. - The ability to communicate effectively in a multicultural matrix organization. - Basic computer skills in Microsoft Word, Excel, and PowerPoint. If you are a detail-oriented professional with a passion for ensuring product quality and compliance with regulatory standards, we invite you to apply for this challenging and rewarding position as a Manager - Corporate Quality Audit at Sun Pharmaceutical Industries Ltd.,