Operational Excellence Facilitator

summary

Develop and execute improvement activities within Quality Control, Quality Assurance, Operations, Supply Chain and Engineering. Work with Quality Control, Quality Assurance, Operations, Supply Chain and Engineering to ensure all cGMP aspects of activities are maintained. Interact daily with Operations and Quality groups to drive activities implementation and track ongoing success against completed tasks. Provide individual contributions to problem solving efforts on selected processes and equipment to improve Quality, reduce cost and improve processing cycle times. Implement best practice mindset within work functions and function as key change agent for business system improvements.  Apply tools from Cognitive Science to redesign and simplify QC Lab documents including Operations and Engineering.

essential Duties and Responsibilities

• Utilize technical expertise to provide a systematic approach in applying Cognitive Science to standard operating procedures, test methods and related documents.
• Determine viable solutions and then develop alternative options to build and/or modify documents that will correct or improve human errors.
• Perform self-inspections of QC Lab, Operations, Engineering and Supply Chain to identify opportunities for improvement.
• Benchmark internally (within Nesher) and externally (With Zydus) to provide "Best in Class" guidance for turnaround time of In-process material and finished products tested by Quality Control.
• Write and maintain progress reports files and look for opportunities to leverage "Lessons Learned" throughout the entire organization.
• Use tools such as Process Mapping and Value Stream Assessment to identify opportunities to maximize efficiencies in manufacturing Quality Control and Manufacturing.
• Manage Cognitive Science projects.
• Interface with all areas of the plant and all levels of management.
• Use innovative concepts in accordance with company objectives to solve complex problems in creative and effective ways.
• Work on complex issues in which analysis of situations or data requires an in-depth evaluation of intangible factors.
• Exercise judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
• Act independently to determine methods and procedures on new assignments.
• Work with Compliance Team to analyze Human Error trends.
• Adhere to all cGMPs, compliance/regulatory mandates and quality requirements.
• Perform other related duties as assigned to meet Company objectives.
•  

KNOWLEDGE/SKILLS/ABILITIES

• Detailed working knowledge of Cognitive Science, QC Lab Testing, Analytical techniques, cGMP regulations and compliance.
• Proven communication skills to communicate in a clear, concise manner whether in oral, written or presentation form.
• Strong interpersonal skills to effectively establish and maintain collaborative cross-functional working relationships with all levels throughout the organization and outside business partners.
• Organizational skills to effectively manage multiple tasks and documents revision.
• PC proficiency using Microsoft Office Suite.

EDUCATION/EXPERIENCE

• Bachelor's degree in sciences or engineering.
• Minimum five years' progressive experience in pharmaceutical or other highly regulated industry.
• Quality Control/Quality Assurance experience with strong analytical background.
• Lean Six Sigma Training preferred.
• Cognitive Science Training.Work environment
•  

The physical demands described here are representative of those that must be met by an individual to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job the individual is required to:

1. Stand, walk, sit, balance, stoop or crouch, kneel, reach, push, grasp, feel, talk, and hear.
2. Have clarity of vision at 20 feet or more and 20 inches or less with the ability to judge distance and space relationships, bring object into sharp focus and see up and down or to the right or left while fixed on a point. Must also have the ability to identify and distinguish colors.
3. Exert an amount of force continuously and/or up to 5 pounds of force frequently and/or up to 25 pounds of force occasionally to lift, carry, push, pull, or otherwise move objects.

The work environment characteristics described here are representative of those an individual encounters while performing the essential functions of this job:

1. Individual is in a proximity to moving mechanical parts and exposure to chemicals.
2. Individual may be required to wear respiratory devices that include but are not limited to: Air Purifying Respirators (APR) which include half-face and full-face negative pressure respirators, hooded powered air purifying respirators, or Supplied Air Respirators (SAR), which include hooded or full face supplied air respirators.

Current Openings for Operational Excellence Facilitator Jobs at Nesher Pharmaceuticals (USA) LLC