Quality Assurance Manager & Qualified Person Abbott Pharma Israel
AbbottTel avivUpdate time: August 27,2021
Job Description

Abbott Established Pharmaceuticals in Israel is looking for a Quality Assurance Manager & Qualified Person

In this position you will drive compliance with the company’s policies and procedures, and local regulation/legislation requirements to meet statutory, quality and business requirements within the overall strategy and objectives of Abbott Laboratories Ltd. and Israeli MOH (the Israeli Ministry of Health).

CORE JOB RESPONSIBILITIES:

  • Develop & maintain high standard quality systems, divisional policies/procedures and regulations related to Quality for the Israel Affiliate.
  • Ensure local Affiliate QA Policies and Procedures are up-to-date in accordance with MOH regulations, GMP regulations & applicable external local requirements/regulations and in accordance with Abbott’s global procedures.
  • Coordinate training programs related to Affiliate Quality System education, ensuring all relevant employees are trained & records maintained.
  • Develop and manage an overall customer complaints system (including device complaints, if applicable).  Review complaint data regularly, identifying trends for continuous improvement & preventative actions. 
  • Provide input and assist the RA Manager regarding any QA-related activities and keep the Manager abreast of any practices that could impact Abbott’s products and/or processes.
  • Maintain appropriate management of the Change Control process in the IL EPD according to local and global SOPs.
  • Complete periodic QA reconciliation with interacting departments and/or partner companies and acts upon any discrepancies.
  • Conduct QA internal audits & inspections; facilitate & direct all external audits/regulatory inspections.
  • Conduct QA management Review.
  • Support and coordinate Third Party Warehouse (TPW) operations regarding all QA compliance activities as required (Batch release, Overlabeling, Cold shipments, Complaints, etc.).
  • Perform local QP release.

QUALIFICATIONS ​:

Education:

  • Bachelor's degree in Pharmacy - must
  • Certified pharmacist by the Israeli MoH - must
  • Certified QP by the Israeli MoH - must

Experience & Background:

  • At least 2 years of experience as QP and batch release - must
  • At least 2 years of experience in Quality Assurance - must

Personal Qualifications and skills:

  • We’re looking for A teamworker, an Initiative and Innovation person, with enthusiasm for achievement, strong Planning and prioritizing skills, and of course a people's person.

Do you like the sound of this job and think you’ve got what it takes?

Then send us your CV today. We look forward to receiving your application online in pdf format.

Connect with us at www.abbott.com, on LinkedIn at www.linkedin.com/company/abbott-/, on Facebook at www.facebook.com/Abbott

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