About the Job :
The firm has more than 130 years of history and one of the largest health care company, this keeps its products in every stages of life. Johnson & Johnson strives to improve the quality of medicine by improving the access and affordability of medicine to the people all over the world. Foundation to vibrant lives is their main motto in the delivery of medicines. 1.3 million employees work with united heart to change the health of the humanity. Diversity is a core part of the company’s culture. Women empowerment is one of the key pillar in the company, encouraging women employee’s since 1886.
3 amazing principles in the Alzheimer’s disease. Debuts the new devise medical center at Texas. Numerous products starting from baby care products, Health care, healing products, orthopedics, surgery, interventional solutions and vision.
Pharmaceutical products including immunology, Cardio vascular, Pulmonary, Neurosciences & Metabolic diseases along with oncological drugs plays a vital role in improvising patients lives for a better society.
Recently it started in Global preventive HIV vaccine which brings an exciting milestone. The company named fortune 2019 as the most admired company, bagged top rank in linked index. Branches includes all over the world established a giant root in the pharmaceutical industry.
Right from 1887 with the introduction of papoid tablets to band aids introduces many products in the market for mankind.
About the Job :
Experience : Bachelors with 10-12 years of experience with FDA handling exposure
Roles & responsibility
Ensure compliance of Quality Make operations with applicable regulations and policies including local and international standards
Review and approval of validation documents for manufacturing, utilities / facilities, and microbiology functions.
Partners with R&D and other cross functional partners to ensure the proper application of design controls, risk management and the investigation/correction of design failures/challenges.
Improve overall efficiency of the Quality Make through use of Process Excellence, Lean principles, and Data analysis.
Support NCR / CAPA/ Complaints/ Internal Audit/ External Audit process.
Support the Quality Systems used to improve product quality, process and customer satisfaction
Mentor, train and supervise the Quality Make staff.
Responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable
Make recommendations to management regarding ways to improve Quality and Manufacturing processes in support of current requirements of Good Manufacturing Practices.
Provide inputs for annual business (budget) planning process.
Utilize cost control initiatives to reduce expenses.
Responsible for communicating business related issues or opportunities to next management level
Review/analyze whether current product and processes (including actions or decisions conducted) are complying to standards ISO 13485 and other applicable regulations / standards.
Supports the development of quality strategies related to the transfer of products, materials, and components within J&J or externally. Supports new product / process / equipment introduction as part of design transfer.
Performs other duties assigned as needed.
Conduct investigation, bounding, documentation, review and approval of non-conformances, CAPAs and customer complaints. Escalation of quality issues as appropriate.
Conduct strategic planning with site leaders. Partnership with other functions to establish business priorities and resource allocation and Performs other duties assigned as needed.
Accountability and ownership of Quality metrics including maintenance and reviewing of leading and lagging indicators of quality.
Approve IQ, OQ, PQ, TMV or Software Validation.
Responsible for ensuring personal and Company compliance with all Federal, State, local and Company regulations, policies, and procedures.
Partners with J&J Global Supply chain, Finished Goods and material suppliers to ensure appropriate application of process validation, process control, and risk management; and the investigation/correction of process failures when needed.
Develop measurement systems/capabilities, destructive tests, non-destructive tests for new product / process, if any.
Develop control plans consistent with product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls etc. for new product / process.
Ensure that customer CTQs are known and adequately addressed in control plan.
Assess the need for risk mitigation techniques given product classification, potential defect types, defect frequency, severity, patient risk, process capability, process controls, etc. Determine effectiveness of these techniques on previously implemented improvements
Ensures effective quality strategies are created for the validation of test methods, process and design of new product / process.
Document, justify, review or analyze whether a proposed change to a process will not enhance the risk level in some way beyond capability of current controls or whether change will result in potential non-compliance to a required standard / regulation.
Shall act as backup for Change Management, Complaint Management, Periodic Validation, QSMR and IPQA processes.
Responsible for communicating business related issues or opportunities to next management level.
For those who supervise or manage a staff, responsible for ensuring that subordinates follow all Company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable.
Develop, interpret, and implement appropriate process monitoring and control methods consistent with the level of process/product risk for new product/process.