Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices markets. Johnson & Johnson strives to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life. The organization is comprised of more than 250 operating companies with over 127,000 employees located in some 60 countries. With Global sales of USD 71.3 billion in 2013, Johnson & Johnson is recognized as one of the most admired and respected companies in the world. Johnson & Johnson companies are equal opportunity employers.
Post : Senior Executive Quality
Main duties and responsibilities
Responsible for finish goods manufacturing records review and approval in SAP as a quality assurance representative
Responsible for complaint management system for the site
Responsible for compilation of Annual product review data on quarterly basis.
Responsible to share with the management monthly product release performance and opportunities identified on a monthly basis.
Responsible for records keeping as per local and franchise guidelines.
Additional duties and responsibilities
- Ensure that performance and quality of products conform to established company and regulatory standards.
- Submit and administer budget schedules for the department.
- Follow site manufacturing quality system as per local Drugs & Cosmetic Act, Schedule MIII, ISO 13485 current requirements.
- Ensure due date adherence to quality system metrics wrt deviations, external internal audits and CAPA actions
- Ensure that data is analyzed and appropriate feedback is given to management on periodic basis.
- Ensure timely escalations happen to the management for product quality issues and complaint data signals
- Ensure that he abides by the company practices wrt safety data integrity.
Authorized to release the finish devices in SAP
Authorized to approve or sign the product graphics
Procedure review in the current document management system
Final approval of product analysis/investigation related to complaints
5-8 years of experience in Medical device or pharm industry in QA role.
Exposure to regulatory submission will be added advantage
Experience: 5-8 years
Location: Greater Mumbai, India
Industry Type: Pharma
Functional Area: Quality Assurance
Last date : 25th May, 2017
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