Operational Excellence Executive

Responsibilities

• Gain knowledge and provide training on cGMP, GDP, Data Integrity, GLP, Microbiology, and other GxP topics relevant to employee job profiles.
• Ensure all employees involved in GMP activities undergo mandatory annual cGMP training.
• Conduct mandatory microbiology training for employees working in GxP environments.
• Provide guidance and recommendations to ensure compliance with DI and GDP in documentation.
• Ensure documentation meets ALCOA principles (Accurate, Legible, Complete, Original, Attributable).
• Perform FMEA (Failure Mode and Effects Analysis), capability analysis, and corrective actions for development and released products.
• Conduct statistical analysis using Six Sigma tools to support process improvement.
• Drive continuous improvement initiatives, including root cause analysis and corrective action implementation.
• Implement and verify standard processes, procedures, and documentation.
• Evaluate products and processes, suggesting improvements in equipment and workflows.
• Participate in the development and delivery of quality-related training programs.
• Support troubleshooting activities to resolve process deviations and ensure compliance with regulatory standards.

Requirements

• Bachelor's degree in Pharmacy, Biotechnology, Engineering, or related field.
• Minimum 35 years of experience in pharmaceutical manufacturing, quality assurance, or operational excellence roles.
• Strong knowledge of cGMP, GDP, Data Integrity, and GxP compliance requirements.
• Hands-on experience with Six Sigma tools, FMEA, and statistical process control.
• Proven track record in continuous improvement and troubleshooting within a regulated environment.
• Excellent documentation skills with attention to detail and adherence to ALCOA principles.
• Strong analytical, problem-solving, and communication skills.
• Ability to train and mentor employees on compliance and quality standards.
• Familiarity with microbiology concepts and their application in GxP environments is an added advantage.

Competencies

• Process improvement mindset.
• Strong leadership and collaboration skills.
• Ability to work under pressure and meet tight deadlines.
• Commitment to compliance, quality, and operational excellence.