Executive Quality Operations

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).