Janssen India, the pharmaceutical division of Johnson & Johnson India, is dedicated to addressing and solving some of the most important unmet medical needs of our time in India, in oncology, immunology, neuroscience and analgesia, dermatology, infectious diseases and metabolic diseases. Driven by a strong dedication to the health and well-being of patients, Janssen India brings innovative products, services and solutions to people throughout the world.
Post : Product & Process Quality Lead
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.
• Has Knowledge and experience of Process validations, Facilities validation, Microbiology & QC Test Method Validations.
• Has Knowledge and experience of Change Control, BOM processes & SAP system.
• Mentor, train and supervise the Product & Process Quality staff.
• Improve the efficiency of the Product & Process Quality using process excellence and lean principle .
• Communicate department objectives and metrics.
• Develop and analyze statistical data and product specification to determine present standards and establish proposed quality and reliability expectancy of finished product, including raw material, in process and finished goods.
• 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 system quality and customer satisfaction to quality assurance staff.
• Ensure resolution of daily Product & Process Quality issues, inter and intra department.
• Provide inputs to Product & Process Quality 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 Product & Process Quality function and provides technical support and information to production and Utilize cost control initiatives to reduce expenses.
• Responsible for managing overall site Product & Process Quality Program in compliance with all applicable regulations and policies, including FDA, safety and environmental.
• Responsible to formulate, coordinate and meet Product & Process Quality 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 5-7 years relevant experience in Quality Assurance / Quality Control function in Pharmaceutical/ Medical Device industry.
• Green belt certification in lean six sigma with demonstrated experience in quality projects
• 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, Software’s used to operate UV Spectrophotometer, FTIR Spectrophotometer, HPLC, GC, Stability Chambers, etc.
Technical & Behavioral Skills
• 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 Laboratory 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 : 5-7 years
Qualification : Graduate in Pharmaceutical Sciences / Postgraduate in Science
Location : Maharashtra-Aurangabad
Industry Type : Pharma / Healthcare/ Clinical research
Functional Area : Quality
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