Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing creative ideas, products and services to advance the health and well-being of people. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.
Our Consumer Business touches a billion lives around the world and works with the vision of 'Bringing science to the art of healthy living'. In India, the company touches the lives of consumers through businesses spanning baby care, women's health, beauty, oral & wound care and over-the-counter-products which are endorsed by healthcare professionals around the world. In India, the company touches the lives of consumers through Baby Care, Women’s Health, Beauty, Oral & Wound Care and OTC. Some of our key brands include Johnson's® Baby, Stayfree®, Clean & Clear™, Band-Aid®, Listerine®, ORSL and Benadryl®.
Purpose of the position:
Responsible for plant QA function of Q&C; work effectively for GLP/GMP compliance in laboratory and Plant. Responsible for timely disposition of the product by ensuring end to end compliance against J&J quality Policy, Standards and local regulatory requirements and deploy QMS to keep plant all time audit readiness. Also, responsible to collaborate with site leadership team, stake holders and Regulatory Affairs to work proactively towards regulatory requirement. Also responsible for successful delivery of Business strategy, Key Performance Indicators (KPIs) and timely escalation of Quality events and Regulatory challenges for broader discussion, guidance and resolution.
Ensure effective implementation of Good Manufacturing, Laboratory & Documentation practices.
BMR Revision and Management which includes preparation and revision of BMRs for the new as well as already existing products (as and when required) including Improvements in BMRs.
Preparation, review and issuance of Master and control copy as and when required.
Knowledge of Stability Management which includes preparation of Protocol, Stability reports, Stability Planner review of stability chamber’s daily printouts
Knowledge of SAP quality Module specially for material and product disposition
Sound Knowledge of QMS for handling Change control, Investigational and CAPAs
Exposure to equipment, instruments and utility qualification documents and review VMP, Scale up and Process validation protocol & reports (Manufacturing, packing and C&S)
To be part of plant team for execution of product validation for NPD/NPI.
To ensure CSV compliance at site
Successful inspections by Health Authorities / External Agencies.
Compliance to the conditions of the License as per Drugs & Cosmetics Act, 1940 and Rules 1945.
Compliance to Schedule L1 for the Quality Lab.
Compliance w.r.t GMP, Internal Audits, JJRC, MRASS and any other External Audits.
Academic & Technical Qualification
Master’s degree in Chemistry or Equivalent
CTS Approval (Preferred)
Computer Literacy: Good working knowledge of MS Office.
Experience: 3 to 6 years in relevant Industries
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.
Johnson & Johnson Private Limited (8080)