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.
Post : Executive Quality Operations
Job purpose of Executive Quality Operations is to plan, coordinate and direct Quality operation designed to ensures continuous production of products consistent with established standards by performing the following duties and responsibilities.
Duties & Responsibilities
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
• Ensure Product & Process Quality operations in compliance with applicable regulations and policies, including FDA, safety and environment and ensure that Good Manufacturing Practices (GMP) are followed on shop floor.
• Lead In-Process Quality Assurance process and activities as part of Quality Operations.
• Ready to work in Shifts (Ist, IInd & IIIrd) as per business requirement in manufacturing environment.
• Has Knowledge and experience of Change Control, Validation, Nonconformance, CAPA, PQR, QSMR & SAP system.
• Train and supervise the IPQA staff.
• Improve the efficiency of the IPQA using process excellence and lean principles.
• Communicate department objectives and metrics.
• Assure personnel are properly trained and developed for their function and future responsibilities.
• Communicate metrics and systems used to measure and guide improvements to product and quality system and customer satisfaction to quality operations staff.
• Ensure resolution of daily IPQA issues, inter and intra department.
• Provide inputs to IPQA reports, requirement and other information in response to requests for proposals, quotes and other business opportunities.
• Review of Sterilization records for autoclave and EO sterilization.
• Make recommendations to management regarding ways to improve manufacturing processes and increase product quality and delivery while reducing production cost.
• Responsible for revision/creation of documents like SOP & QAP required for manufacturing the product.
• Ensure the correctness and availability of the artwork (Product Graphics) to enhance market acceptability.
• Ensure compliance to Quality System requirement.
• Utilize problem solving skills and statistical techniques to support product / processes control that are aligned with the overall quality and business vision.
• To represent Quality Operation function and provides technical support and information to production and Utilize cost control initiatives to reduce expenses.
• Responsible for managing overall site Quality Operation Program in compliance with all applicable regulations and policies, including FDA, safety and environmental.
• Responsible to formulate, coordinate and meet Quality operations objectives & strategy.
Compliance & Training
• Observes & promotes all regulatory requirements as defined per applicable regulations, rules & procedures established by the Company, and notify any violation or deviation to the immediate supervisor or appropriate authority.
• Complies with all training requirements to perform duties of the job.
• Ensure adherence/compliance to Records Management policies and procedures, as applicable.
• Graduate in Pharmaceutical Sciences / Postgraduate in Science / Bachelors in Engg. with minimum 4-6 years relevant experience in Quality Assurance / Quality Operations/Quality System function in Pharmaceutical/ Medical Device industry.
• Green belt certification in lean six sigma with demonstrated experience in quality projects is preferred.
• Experience of working in a regulated industry like Pharmaceutical / Medical Devices is highly desirable.
• Working knowledge of Laboratory Software’s is preferred. For example, LIMS system, ETQ NC, ETQ CAPA, Trackwise, etc.
• Demonstrate knowledge and application of MDR 2017, Drugs & Cosmetics Act, ISO-9001, ISO-13485 and other relevant international standards for medical devices.
• Knowledge of applicable laws and regulations, manufacturing environment.
• Thorough understanding of process criteria and regulations and business impact of decisions and actions.
• Ability to initiate, explain and sell innovative thought process and ideas.
• Ability to technically review documents from other areas for departmental impact.
• Strategic thinker as it pertains to compliance programs with strong leadership ability, interpersonal relationship, communication and influencing skills.
• Strong technical, planning and execution capabilities.
• Ability to analyze, balance and prioritize risk.
• Acquaintance with Good Manufacturing Practices, Machines and Equipment(s).
• Operational excellence in Quality and Compliance activities.
• Apply business fundamentals.
• Apply business partnering.
• Proficient in MS Office (MS Excel, MS PowerPoint, MS Word)
Very good presentation & Report Writing skills
Budget Management & Expenses reporting
Business Excellence and Cost Savings/management
Experience : 4-6 years
Qualification : Graduate in Pharmaceutical Sciences / Postgraduate in Science / Bachelors in Engg
Location : Aurangabad
Req No : 2206090605W
Functional Area : Quality Assurance
End Date : 25th December, 2022
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