QA Engineer CAPA Admin

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 involved in QMS related activities applicable to regulatory compliance- corrective and preventive actions, Corrections, QMS maintenance including procedures, management review, Quality KPIs and trending.

Essential Duties And Responsibilities

• CAPA Administrator
• Leading corrective actions including event registration, investigation with relevant departments, identifying root cause, setting actions.
• Leading preventive actions including event registration, investigation with relevant departments, identifying root cause, setting actions.
• Managing the CAPA process- verifying compliance with applicable procedures, action items follow ups, tracking and trending.
• Leading Low risk CAPAs (corrections) including event registration, verifying investigations with relevant departments, identifying root cause, setting actions.
• Perform Root Cause Analysis (RCA) through the identification of the cause of failures, with the use of root cause analysis methods.
• Set up routine CAPA meetings that includes applicable departments representatives, involve specific SMEs during investigations.
• Lead the CAPA forum by collecting and analyzing data related to CAPA/ Low risk CAPA (Corrections), present and identify trends.
• Root Cause Analysis SME- support investigation processes done by other groups/teams and be the focal point for investigation methods.
• Maintaining quality system procedures by verifying their compliance to relevant regulatory requirements.
• Execute preparations of periodical management reviews and Quality reports.
• Representing the CAPA/Corrections process during customers and regulatory authorities’ audits
• Support other QA/MQ dept activities- batch release/graphics, audits, CAPA/ Low risk CAPA (Corrections), customer complaints, QA monthly report, KPIs.
• Overdue Training - Managing overdue training including performing risk assessments verifying that affected personnel did not use or operate under untrained procedures, and documenting required controls.
• Training File & Qualification Alignment- Periodic review of employee training files together with HR to ensure alignment between role requirements, training assignments and qualifications.
• Periodic Review of Systems validations - Quality focal point for periodic system reviews to ensure compliance and up‑to‑date documentation.
• Document Control Support- Supporting document control activities including document release, distribution and compliance with document control procedures.
  
  

• As appropriate, use knowledge and experience to identify initiatives to improve the effectiveness and/or efficiency of systems.
• Work independently without supervision.
• Other duties as assigned.
  
  

• Education: B.Sc./ BA. in Chemistry/ Biology/ Eng./ Science – an advantage
  
  

• At least 2 years working in quality system/regulatory in the Medical Device industry or pharma industry.
• Experience with root cause analysis methods- Ishikawa- fishbone, FTA, Cause and Effect Analysis, 8D, 5 M’s, 5 whys, etc.
• Experience with ISO 13485, MDSAP and CE audits - an advantage
  
  

• Courses on topics related to quality system/regulatory requirements in the medical device
• Proven knowledge with ISO 13485, MDSAP, MDD 93/42/EEC and MDR 2017/745
• English- high level in both verbal and written
• Certified auditor- an advantage
  
  

• Organizational skills will enable planning, prioritization & achievement of goals especially of importance for the successful execution of customer visits and business development related activities
• Work in an office environment. At times must sit for extended periods of time.
• Observe and interpret situations, analyze and solve problems
• Must maintain the ability to work well with others in a variety of situations
• Must be able to multi-task and work under time constraints
• Ability to make independent and sound judgments