QA Engineer, CAPA Admin
West Pharmaceutical Services
full-time
Posted on:
Location Type: Office
Location: Ra'anana • Israel
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About the role
- Involved in QMS related activities applicable to regulatory compliance- corrective and preventive actions, Corrections, QMS maintenance including procedures, management review, Quality KPIs and trending.
- 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.
- Performing Root Cause Analysis (RCA) through the identification of the cause of failures, using root cause analysis methods.
- Setting up routine CAPA meetings that includes applicable departments representatives, involve specific SMEs during investigations.
- Leading the CAPA forum by collecting and analyzing data related to CAPA/ Low risk CAPA (Corrections), present and identify trends.
- Supporting 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.
- Executing preparations of periodical management reviews and Quality reports.
- Representing the CAPA/Corrections process during customers and regulatory authorities' audits.
- Supporting other QA/MQ dept activities- batch release/graphics, audits, CAPA/ Low risk CAPA (Corrections), customer complaints, QA monthly report, KPIs.
- Managing overdue training including performing risk assessments verifying that affected personnel did not use or operate under untrained procedures, and documenting required controls.
- 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.
- Supporting document control activities including document release, distribution and compliance with document control procedures.
Requirements
- 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.
Benefits
- Supported by benefit programs
- Empower the physical, mental, emotional and financial health of our team members and their families.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
root cause analysiscorrective actionspreventive actionsCAPA processquality system maintenancequality KPIsevent registrationdata analysisdocument controlrisk assessment
Soft Skills
leadershipcommunicationcollaborationproblem-solvingorganizational skills
Certifications
B.Sc. in ChemistryB.A. in BiologyCertified auditor