Work as Senior QMS Lead at Johnson & Johnson


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 QMS Lead

Job Description
• Ensure Quality Assurance operations in compliance with applicable regulations and policies, including FDA, safety and environment.
• Ensure that Good Manufacturing Practices (G.M.P.) are followed on the shop floor
• Mentor, train and supervise the quality assurance staff.
• Improve the efficiency of the Q.A. through the use of Process Excellence and Lean principles.
• Communicate department objectives and metrics.
• Develop and analyze statistical data and product specifications to determine present standards and establish proposed quality and reliability expectancy of finished product; including raw materials, in-process and finished products.
• Ensure resolution of daily quality Assurance issues, inter- and intra-department
• Conduct reviews of SOP’s, specifications and validation documentation in ADAPTIV system.
• Review of sterilization records for autoclave and EO sterilization.
• Provide input to budget planning process.
• Utilize cost control initiatives to reduce expenses.
• Make recommendations to management regarding ways to improve manufacturing processes and increase product quality and delivery while reducing production costs.
• Accountable for eliminating significant quality issues on shop-floor.
• To represent Q.A. function and provides technical support and information to Production and Sales/Marketing
• Conduct detail review and gap assessment of external and internal standard as per PR-0000588 Franchise procedure for management of External standards, directives and regulations
• Ensure non-conformance program is implemented and is effective. Ensures that data is analyzed and appropriate feedback is given to management on periodic basis.
• Ensures Corrective action and Preventive action process is implemented effectively. Ensures that data is analyzed and appropriate feedback is given to management on periodic basis.
• Conduct CAPA review board & QSMR (Quality System Management Review) meeting.
• Conduct annual product review.
• Finished product release
• Handle change control management.
• Perform complaint investigation & handle product complaint management.
• Handle Field action management (Product Recall)

Candidate Profile
B. Pharmacy or M. Pharmacy with post graduate diploma in TQM or RA.
Experience: 7 to 10 years’ experience in pharmaceutical or medical devices industries.

Specific skills: Proficiency in MS office, SAP ERP system, Compliance Wire, Document Management system, LIMS and ETQ Track wise system.

Additional Information
Experience : 7 to 10 years
Qualification : M.Pharm, B.Pharm
Location : Bihar-Aurangabad
Industry Type : Pharma
Functional Area : Quality Assurance
End Date : 30th September, 2018


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