Subject Matter Expert - Pharma

• Subject Matter Experts with experience designing and deploying MES & electronic batch record systems in the pharmaceutical industry preferably with related or non-related Plant Applications experience.
• knowledge in Pharma domain and manufacturing process. The candidate should have experience designing and deploying MES & electronic batch record systems in the pharmaceutical industry.
• Client-X knowledge would added advantage.

Must Have Skills:

• In-depth knowledge on Pharma Industry process.
• Having good experience in Pharmaceutical and Manufacturing domains
• Monitor and review product quality standards and process performance to identify areas of non- compliance.
• Lead monthly quality audit activities to ensure compliance with QMS requirements.
• Develop and maintain key process indicators and other quality metrics to track performance and identify areas of improvement.
• Monitor and analyze product performance data to identify potential issues and areas of risk.
• Root- Cause Analysis
• Problem Solving
• Documentation
• Team Leadership
• Auditing
• Requirement classification skills

Experience

15 to 25 years