13/01 Janaki Devi
HR at Johnson & Johnson

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Johnson & Johnson - Senior Executive - Quality Assurance (0-1 yrs) Premium

Mumbai Job Code: 881428

Caring for the world, one person at a time, inspires and unites the people of Johnson & Johnson. We welcome innovation- bringing ideas, products and services to life to advance the health and well-being of people around the world. We believe in collaboration, and that has led to breakthrough after breakthrough, from medical miracles that have changed lives, to the simple consumer products that make every single day a little better.


Our over 125,000 employees in 60 countries are united in a common mission: To help people everywhere live longer, healthier, happier lives. In India, J&J operates as a single legal entity and consists of the 3 strategic business units: Consumer Health, Pharmaceuticals and Medical Devices, which are independently handled and report into their respective Global business segments

J&J Medical India (JJMI) is the market leader in the Medical Company Devices Industry in India. It is in the business of caring and providing solutions to doctors, patients and nurses. It comprises of multiple Franchises (Strategic business units) providing healthcare solutions across Vision Care, Orthopaedics, Infection Prevention, Wound Management, Women's health, minimally invasive surgery, Circulatory disease management, and Blood glucose monitoring and insulin delivery.

Responsibilites:

- Execute the activities related Complaint Management with proficiency in using the associated tools

- Effectively use the QMS tools like TruVault, Trackwise, SUMMIT, Unity etc.

- Execute activities related to internal and supplier's audits to assure compliance with regulatory requirements, company & international standards.

- Organize, plan, lead and manage quality-related projects in alignment with Organization goals.

- Responsible for the document control, CAPA, NCR and complaint analysis systems and processes. Shall investigate the issues and document and follow up the action plans

- Facilitate 3rd Party audits, i.e. Notified Body, FDA and other regulatory agency compliance inspections as well as Corporate audits and coordinate responses

- Prepare quality reports and develop procedures which affect operational and compliance status and coordination/preparation/presentation of management review.

- Execute the activities related to QMS elements like Document Control, Change Control, Escalations, Quality Issue Management etc.

- Prepare Management Reports (Monthly Reports, Prism / Metric Studio Reports etc.)

- Gain knowledge on ISO 13485 & 9001 standards

- Gain knowledge on Medical Device Rules 2017

Qualifications

Minimum Requirements:

- Bachelor's &/or Master's degree in Science, Graduate in Biomedical Engineering, or equivalent is required. Must have at least 5 - 7 years- experience in the pharma/medical device industry.

- Quality systems implementation and maintenance; GMP/Quality Systems Regulations; ISO13485

- Knowledge and competency in application of Local FDA (D&C act), ISO 13485 and other regulatory requirements especially in Quality Systems.

- Excellent written and verbal communication/presentation skills necessary to meet the needs of various audiences with a demonstrated track record of strong organizational and interpersonal skills. Advanced computer skills specifically in MS Word, Excel, Internet Explorer, PowerPoint, and Outlook.

Are you ready to impact the world?

Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

This description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.

Primary Location

India-Maharashtra-Greater Mumbai-

Organization

Johnson & Johnson Private Limited (8080)

Job Function

Quality

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Women-friendly workplace:

Maternity and Paternity Benefits

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