Work as Senior QMS Lead at Johnson & Johnson

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)

andidate 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