EXECUTIVE QUALITY OPERATIONS

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 , Drugs & Cosmetics Act, ISO , ISO 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).