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Job Information

J&J Family of Companies Executive Quality Operations in Bihar, India

Executive Quality Operations - 2406182671W

Description

Description - External

Quality Assurance Executive - Aurangabad

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 Quality Operations / Quality Assurance in compliance with applicable regulations and policies, including FDA, Safety and Environment.

  • Improve overall efficiency of the Quality Assurance/Quality Operations through use of Process Excellence, Lean principles and Data analysis.

  • Communicate, align, drive & periodically review departmental objectives and metrics with the team members.

  • Assure personnel are properly trained and developed for their function and future responsibilities.

  • End to End Governance of In-Process Quality Assurance process.

  • Drive QA Controlled document issuance process.

  • Support Finished Goods release process.

  • Conduct Batch release in SAP system.

  • Ensure resolution of daily quality operations FG release related issues.

  • Perform Review and Approval of Batch Manufacturing Records (FG & Non-Abs) and FG testing records and take disposition decision of Finished Goods after review of BMR and Test reports.

Qualifications

Qualifications - External

EXPERIENCE AND EDUCATION

  • A graduate in Pharmaceutical Sciences / Postgraduate in Science with minimum 4-6 years relevant experience in Quality Assurance / Quality Operations function.

  • Experience working in both an FDA and European regulatory environment is preferred.

  • 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 Software’s for Complaint management, Change control process, NC/CAPA applications etc. is preferred.

  • 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 drive 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, Good Laboratory Practices, Machines and Equipment(s).

Primary Location Asia Pacific-India-Bihar-Aurangabad

Organization Johnson & Johnson Private Limited (8080)

Job Function Quality Assurance

Req ID: 2406182671W

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