Global Technical Compliance Specialist
hace 4 días
At Genpact, we have the expertise to go deep with the world's biggest brands – and we have fun doing it.
We're calling all you rule-breakers and risk-takers who see the world differently, and are bold enough to reinvent it. Come transform with us
About This RoleThis position is responsible for handling product technical complaints and field alerts for medical devices, pharmaceutical products, biologics, and combination products.
Responsibilities include interacting with complainants, obtaining essential information, providing customer service, identifying and confirming inquiries as product technical complaints, evaluating complaints for severity and risk to public safety, notifying interested departments, monitoring and tracking sample receipt, ensuring timely review and processing of complaints, prioritizing complaints for data entry and processing into the global database, and utilizing the customer service database to oversee complaint identification and processing.
Additionally, this role involves interacting with internal and external manufacturing sites regarding technical complaints and their associated investigations, identifying complaints for field alert reporting, performing QC checks, understanding US FDA complaint regulations for drug products and medical devices, and producing monthly reports listing monthly complaint activity.
The ideal candidate will have a strong understanding of Good Documentation Practices, be able to analyze complex situations, and provide effective solutions. Strong verbal and written communication skills, problem-solving skills, attention to detail, organizational skills, analytical skills, and self-motivation are also required.
Prior experience within the pharmaceutical industry, knowledge of cGMPs and Code of Federal Regulations, project and time management skills, interpersonal skills, customer service skills, ability to multitask in a highly stressful environment, and ability to operate in a constantly changing environment are highly desirable.
Qualifications We Seek- Bachelor's degree from an accredited four-year college or university in Health or Life Sciences
- Associate's degree from an accredited two-year college or technical school in Health or Life Sciences (preferred)
A bachelor's degree/associate degree in science or related field of study, along with experience within the pharmaceutical industry, will be considered equivalent to years of experience. Advanced degrees in lieu of years of experience will also be considered.
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