Johnson & Johnson was founded more than 120 years ago on a revolutionary idea: Doctors and nurses should use sterile sutures, dressings and bandages to treat peoples’ wounds. Johnson & Johnson is ranked by Fortune Magazine as the 3rd most Admired Pharmaceutical Company in the world with an outstanding product range as well as an extensive research base with a number of life saving original research molecules.
Post : Sr. Officer - Q&C
Job Description :
• Ensure compliance to the requirements of applicable Good Manufacturing Practices (Schedule M, U of D&C Act, FSSAI. Legal Metrology etc) in all manufacturing workshops (Band-Aid, Baby Powder, Food – ORSL Base kit & Sanitary Napkins) of the plant.
• Governance to the requirements of Good Laboratory Practices (Schedule L-I of D&C Act) in the Quality Control Laboratory, enabling timely & accurate disposition for incoming materials, intermediates, bulk & finished products manufactured at the plant.
• Ensure compliance to the Regulatory Compliance at the site.
1. Responsible for effective deployment of Quality System elements viz., investigations of Non-conformances/Deviations & Market Complaints, change management, CAPA management, Training program, Internal Audit program, etc. to drive on time and effective closures of the actions identified.
2. Responsible for review of Batch Manufacturing Record and other applicable GxP documents and act as authorized personal for production batch release.
3. Responsible for coordinating with suppliers for the investigations related to material issues during production and ensure the closure of the same in the given timelines.
4. Conduct GMP rounds and ensure quality culture management at shop floor
5. Responsible for governance of timely line clearance, in-process checks and sampling.
6. Ensure Stability management by conducting MPS studies, etc.
7. Conduct trainings on the revised procedures/BMR and drive effectiveness.
8. Ensure closure of observations related to internal and external audit and coordinate with respective stakeholders for timely closure of AAPs.
9. Lead the projects identified in JJPS Projects and support to CIP/Improvement Projects.
10. Responsible for execution of activities allocated by supervisor on timely basis.
11. Preparation of Trend data of Sanpro, Band Aid and Powder for Complaints.
12. Responsibe for preparation of Annual Product Review, wherever applicable.
• Education: M. Pharm/ B. Pharm/ M. Sc. from reputed university.
• Sound knowledge of GMP, GLP and Local Regulations (Drugs & Cosmetics Act of India,
• Bureau of Indian Standards, ISO 9001 etc.)
• Experience: Having around 3-4 years of experience in Quality Control and Quality Assurance function of Chemical and Pharmaceutical Industry.
• Computer Literacy: Good working Knowledge of MS office.
• Good communication & interpersonal skills, flair for quality, team player, quick learner.
• Able to take added responsibilities.
• Keen to learn and improve skills.
• Proactive risk assessment approach
Experience : 3-4 years
Qualification : M.Pharm/ B.Pharm/ MSc
Location : Greater Mumbai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Q&C
End Date : 25th October, 2020
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