Senior Manufacturing Quality Auditor

Description

At West, we’re a dedicated team that is connected by a purpose to improve patient lives that has been at the center of our Company for more than a century. Our story began when Herman O. West solved the problem of supplying penicillin in mass quantities to the US Government during World War 2. Through our work to deliver thousands of life-saving and life-enhancing injectable medicines to millions of patients daily, West’s indelible mark on the healthcare industry has just begun. A name started our story. How will yours help write our future?

There’s no better place to join an inclusive community of professionals with opportunities for lifelong learning, growth and development. Supported by benefit programs, we empower the physical, mental, emotional and financial health of our team members and their families.

We believe in giving back to help those in need in the communities where we live and work. And are equally committed to creating a healthier environment and planet through our sustainability efforts.

Job Summary

In this role, you will be responsible to handle raw materials acceptance activities, NCM reports related to raw materials, calibration of inspection equipment, write and update procedures and forms related to incoming inspection. Maintain COC/COA provided by the suppliers and issue COC/COA for raw material in accordance with requirements. Adhering to Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP) is essential to maintain all documentation necessary to ensure conformity to specifications and traceability of records.

Essential Duties And Responsibilities

• Lead the process for raw materials acceptance activities in ERP/SAP, including approval of acceptance records generated by incoming inspectors and issuance of Certificate of Compliance for approved raw material.
• Responsible for calibration management of equipment, including the coordination of calibration with the calibration lab, follow up, approval of calibration record and open deviation if needed.
• Leading the Quarantine area and maintain requirements according to procedures.
• Responsible for handling of all related incoming inspection including verifying that all acceptance test results follow GMP and GDP guidelines and non-conforming materials (NCM) – opening and supplying relevant data for occurred deviation.
• Responsible to write special inspection or rework instruction related to incoming process. Leading the process of implementation and update of incoming inspection forms and procedures.
• Leading the process of the approval of all graphic and label related raw material.
• Responsible for the approval of line clearance performed by quality inspectors.
• Assist with Changes (ECO) to improve or clarify established procedures.
• Perform other duties as assigned based on business needs.
  
  

• Education - Technical/ Practical Eng. Or equivalent.
• 5 years of relevant experience in Quality in the Medical Device/pharma industry- an advantage
• Courses related to Medical Device regulation - an advantage.
• Knowledge with ERP/ SAP - must
  
  

• Able to be aware of all relevant standard operating procedures as per Company policy as they are related to the position covered by this Job Description.
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target.
• Able to comply with the company’s safety policy at all times.
• Able to comply with the company’s quality policy at all times.
• Ability to work under pressure.
• Good interrelation skills
• Technical ability - ability to read technical drawings with High Learning ability.
• Excel - basic knowledge and experience.
• Written and verbal communication skills: Hebrew - Mother tongue. English - Good
• Relevant work history and/or experience may be considered in lieu of degree.
• Provide a “Customer Service” attitude when interacting with internal and external customers while accomplishing work, production, and achieving quality standards.
  
  

• Must be able to travel up to 0% of the time
  
  

• Very Heavy/ Heavy/ Medium/ Light/ Sedentary: Medium
• List any mental requirements:
• Ability to work under tight schedule.
• Ability to work in a team and a single worker and promote tasks.
• Ability to ensure high quality work at all time.
  
  

• Approval / Rejection of raw material
• Handling of NCM reports
• Sending COC for released raw materials
• Release raw materials in ERP system
• Update Procedure / Forms related to Incoming Inspection