Job Description

DescriptionKenvue is currently recruiting for:Analyst I, Compliance VigilanceThis position reports into Manager Complaint Vigilance and is based at Greater Mumbai.Who We AreAt Kenvue , we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we're the house of iconic brands - including NEUTROGENAxc2xae, AVEENOxc2xae, TYLENOLxc2xae, LISTERINExc2xae, JOHNSON'Sxc2xae and BAND-AIDxc2xae that you already know and love. Science is our passion; care is our talent. Our global team is made up with 22,000 diverse and brilliant people, passionate about insights, innovation and committed to deliver the best products to our customers. With expertise and empathy, being a Kenvuer means to have the power to impact life of millions of people every day. We put people first, care fiercely, earn trust with science and solve with courage - and have brilliant opportunities waiting for you! Join us in shaping our future-and yours. For more information, click here .What You Will DoKey Responsibilities

• Reviews, evaluates product quality complaints, and processes cases in accordance with Standard Operating Procedures using the Complaint Management System. This may include, but is not limited to, review complaint cases to verify customer verbatim, lot number, subject coding, trend analysis, investigation, and complaint closure as applicable, and escalate, as needed.

• Analyzes complaint data for timely processing and investigation of complaints and reviews with site (manufacturing/ marketing company) to ensure compliance.

• Reviews and processes updated information for complaint "change logs" from call center and medical safety to assess impact on triage and investigation.

• Collaborates with Call Center, Medical Safety, Internal affiliates, External sites, and other business partners as needed for case processing and to ensure compliance. Ensures all relevant data for complaints are obtained and well documented in accordance with closure timelines.

• Assists with developing presentations for complaint vigilance as needed and creation and updates of controlled documents.

• Monitors complaint records in system to ensure standard process is being followed and complaints are closed as required.

• Prepare reports as requested. Supports internal and external audits as needed.

• Assists with global and regional projects related to process and system implementations and improvements within the department, communicate effectively with all levels of management.

What We Are Looking ForRequired Qualifications

• 4 years' experience in Quality and Compliance in pharmaceutical, medical device, nutritional or related industry experience.

• Knowledge of Complaints management and Regulations.

• Demonstrates knowledge in quality system global regulatory requirements, including ICH Q10.

• Experience working in an FDA regulated environment.

• Demonstrates understanding of basic manufacturing processes and associated GMP compliance requirements.

• Demonstrates understanding of medical/ product quality complaints and associated GMP compliance requirements.

• Able to understand/discern safety, business (legal), and compliance risks related to complaints and in achieving performance objectives/ indicators.

Desired Qualifications

• Decision-making and problem solving: Deals with issues using deductive reasoning, critical analysis skills and systematic approaches.

• Innovation/creativity: resourcefulness, inventiveness, or creativity is required to devise methods, procedures, products, scientific applications etc. Deliver value-added business results through execution and controls.

• Demonstrates accountability with a strong focus on quality and compliance.

• Results and Performance Driven, assumes personal ownership and accountability for business results and solutions.

• Excellent communications (verbal, written and listening) and collaboration skills - demonstrated through work, projects, presentations, accurate information gathering, and productive discussions/results.

What's In It For You

• Competitive Benefit Package

• Paid Company Holidays, Paid Vacation, Volunteer Time, Summer Fridays & More!

• Learning & Development Opportunities

• Employee Resource Groups

• This list could vary based on location/region

Kenvue is proud to be an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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