Overview

Senior QA Associate Job in India at Johnsons and Johnsons

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. 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. Janssen recognizes the impact of serious conditions on people’s lives, and aims to empower people through disease awareness, education and access to quality care in six therapeutic areas. The position is accountable for the oversight and execution of Quality Management Systems and compliance at Johnson & Johnson Private Limited , Janssen Global Small Molecule Stability Centre , APDC Mulund , Mumbai. The position serves as a QA point of contact for all analytical activities supported on site including commercial Stability (Global small molecule hub for stability testing , DP & API) , Registration and developmental stability (including clinical stability programmes) and Analytical method development/validation and life cycle management of analytical methods for global markets . This person supports and co ordinates on all quality related matters and liaise with multiple quality organizations to drive timely resolution of Quality related issues. The position implements departmental strategies and services as the business expert on quality processes and quality management. The position optimizes quality systems and processes and ensures alignment with the worldwide business, applicable local regulations & J&J standards. The position identifies opportunities to continuously improve quality, cost and time factors, consistent with business objectives. Identifies significant quality issues, prioritize for action, and support improvement opportunities and problem solutions. The position plans, coordinates, and directs quality assurance programs designed to ensure effective and consistent processes with established standards by performing the following duties personally or through subordinate Essential Job Duties and Responsibilities Employee is responsible for performing activities in compliance with current established site procedures of safety and quality. Objectives and Responsibilities As a Quality Assurance person, ensure that the quality systems and processes followed at APDC meet the J&J quality policy, J&J standards, local procedures and current applicable cGMP guidelines Compliance to applicable J&J policies, J&J standards, local procedures and applicable regulations for each customer as determined by internal and external audit results. Ensuring that the quality control personnel receive initial mandatory and periodic training on cGMP and Good Documentation Practices Ensuring Quality records are handled adequately and in a compliant way before close out. Work as department training process /document controller as applicable Familiar with Electronic Document Management System Knowledge on controlled Substance management programme Main Duties/Additional Duties/Sphere of authority Personnel To assist all the Stakeholders on site in implementing Quality Systems complying with applicable regulations. Handling of Nonconformance/s Responsible for handling nonconformance/s , Approval of quality records and its final disposition , maintaining oversight on adequate handling and timely closure of nonconformance/s, maintaining oversight on the Quality metrics related to NC Document Management Responsible for approving SOP’s/ WI’s, Protocols and other cGMP documents and ensuring adherence to applicable regulatory requirements, J&J policies, J&J standards & local procedures. Lab Support Responsible for approval of SOP’s/ WI’s, Protocols, Validation plans pertaining to Qualification, Calibration & Preventive Maintenance of lab Equipment. Responsible for QA review & release of Equipment after initial & periodic Qualifications/Calibrations/ Maintenance External Contract Lab Support Responsible for approval of SOP’s /WI’s, Protocols, Validation plans pertaining to Qualification, Calibration & Preventive Maintenance of lab Equipment. Responsible for QA review & release of Equipment after initial & periodic Qualifications/Calibrations/ Maintenance Responsible for conducting audit (as applicable) Corrective action / Preventive action Responsible for reviewing the implementation of corrective and preventive actions as per applicable standard operating procedures to meet cGMP requirements, maintaining the Quality metrics related to CPA process. Change Control Responsible for approval , verification and closure of change controls as per process Training To provide training to personnel at APDC site on Quality System SOP’s, cGMP topics & provide cGMP advice. Ensure timely completion of assigned trainings & Maintain oversight on training metrics. Quality & Compliance Responsibilities Responsible for ensuring that the quality systems and processes followed within APDC meet the J&J quality policies, J&J standards, local procedures and cGMP requirements and applicable regulations as per the need of the market in which the product is/ or would be registered and/ or marketed Internal Auditing and Check Round Program Responsible for participating as lead or co-auditor in Internal Auditing program and follow-up of actions arising from internal audit observation. Responsible for conducting check rounds and follow up with respective department for implementation of appropriate actions to prevent recurrence. Regulatory Inspections To actively participate in regulatory inspection readiness program. To act as spokesperson during regulatory inspections for the assigned responsibilities. Supervisory Responsibilities Responsible for self-development and training. Ensure mapping of Quality & Compliance metrics Support introduction of new systems Identify improvement opportunities Employee safety and health Responsible to follow respective guidelines and SOP’s. Environmental Care Responsible to follow respective guidelines and SOP’s. Financial management Ensure that respective guidelines/practices are observed. Identify cost saving opportunities. Business Policy Follow all applicable company business policies. Credo and Leadership Imperatives Respect and make the Credo Values respected. Practice and implement Leadership imperatives (connect, shape and grow) for customer satisfaction, innovation, mastering complexity, collaboration, organization and people development. Stimulate and encourage new ideas and improvement processes. Cooperate efficiently with the different partners. Qualifications Minimum Qualification for the position: Graduate/Postgraduate/PhD in Science discipline with microbiology background and having thorough knowledge of GMP Regulations with minimum experience of 10 + years in Core Quality Role Quality oversight over microbiology lab will be an added advantage Quality background – quality, quality management, Understanding the linkages in quality and regulatory compliance health authority requirements Knowledge of Quality Management systems is a must (TrackWise is an advantage) Experience with internal and external audits is an advantage Organized, and able to work effectively with people within a complex social, cultural and political environment Must have excellent communication skills, able to inspire trust and quickly build credibility within the Quality & Compliance, Supply Chain, and Commercial organizations. Must have strong collaboration and influence management skills to partner effectively across functions and operating units “hands-on” operational orientation Accountability, with a strong desire to commit, be held accountable and be rewarded for delivering results. Recognizes and builds support for change. Engages in constructive conflict Ability to fit in well culturally in a complex organization Are you ready to impact the world? Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. This description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job Primary Location India-Maharashtra-Greater Mumbai- Organization Johnson & Johnson Private Limited (8080) Job Function Quality Requisition ID 2206037313W

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