کوبل دارو
کوبل دارو

Quality Assurance Specialist

Tehran/Arjantin
Full Time
5 working days 08:30 To 17:15
-
Loan -Bonus -Health insurance -Gym facilities -In-house Medical doctor -Breakfast -Occasional packages and gifts

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201 - 500 employees
Pharmaceutical
Iranian company dealing with Iranian and foreign customers
1380
Privately held
توضیحات بیشتر

key Requirements

2 years experience in similar position
Bachelor Chemistry or Chemical Engineering or Biology / Life Sciences/ Lab Sciences or Biotechnology

Job Description

  • Supporting the monitoring and effective implementation of the Quality Management System (QMS).
  • Ensuring that quality-related activities across the organization are performed in accordance with applicable regulations, GMP/GDP requirements, internal procedures, and quality standards.
  • Supporting the qualification, evaluation, and ongoing monitoring of suppliers, service providers, and contract manufacturing organizations (CMOs).
  • Participating in the preparation, coordination, and follow-up of audits of contract manufacturers, suppliers, and third-party service providers, including the assessment and follow-up of audit findings and CAPA plans.
  • Supporting the preparation for regulatory inspections and external audits, coordinating relevant documentation and responses, and following up on applicable CAPA commitments.
  • Planning and conducting internal audits of company processes and preparing audit reports, including recommendations for corrective and preventive actions (CAPA).
  • Supporting the management and follow-up of deviations, non-conformities, CAPAs, change controls, and other quality-related processes.
  • Reviewing quality and compliance documentation received from contract manufacturers and other external partners, as applicable.
  • Supporting the investigation and resolution of quality issues, including product complaints and other quality-related incidents, in collaboration with relevant departments and external partners.
  • Developing, reviewing, updating, and implementing SOPs, quality procedures, and other controlled documents as required.


Requirements

  • PharmD or Master's degree in Pharmacy, Chemistry, Chemical Engineering, Biotechnology, Life Sciences, or a related field.
  • Minimum 2 years of experience in Quality Assurance within the pharmaceutical industry.
  • Good knowledge of GMP/GDP principles and pharmaceutical quality systems.
  • Experience with audits, CAPA, deviations, change control, supplier qualification, and quality documentation.
  • Experience working with or auditing contract manufacturers, suppliers, or third-party service providers is highly desirable
  • Good command of English, both written and spoken.
  • Strong time-management skills with the ability to prioritize tasks and meet deadlines.

Job Requirements

Age
28 - 35 Years Old
Gender
Men / Women
Military service
Military service must be done
Education
Bachelor| Chemistry Bachelor| Chemical Engineering Bachelor| Biology / Life Sciences/ Lab Sciences Bachelor| Biotechnology
Language
English| Upper Intermediate 70%

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