Quality Assurance

2 - 6 Years    Dubai, United Arab Emirates

Job Description

EDUCATION & PROFESSIONAL EXPERIENCE Degree in natural or applied sciences (Pharmacy, Chemistry, Engineering, Biotechnology) Minimum of 2 years work experience in quality assurance and/or quality control and/or production / distribution in the pharmaceutical industry Knowledgeable in Quality and GMP/GDP compliance. Audit experience is desirable Fair understanding of the quality and regulatory requirements Main areas of responsibility are: 1.Quality Management System - Implementation and maintenance oMaintain up to date knowledge of the relevant legal requirements and GMP/GDP regulations by getting Quality trainings and being informed. oSupport to develop, implement and maintain local procedures, in compliance with the Global Pharmaceutical Quality System Documents as well as with local legislation and GMP & GDP standards. oSupport to evaluate product Quality issues and Discrepancies performing the root cause analysis and ensuring that appropriate Corrective and Preventive actions are taken. oSupport to manage product Complaints, Recalls and Returns, when required oSupport to identify, organize and conduct training of personnel involved in GxP activities oSupport to implement and manage Change control, local Corrective and Preventive Actions and Quality Risk Management procedures as per the local SOP and ROCHE guidelines oProvide timely feedback and guidance for dealing with internal and external inquiries about the products quality oSupport and maintain local supply chain quality risk management plan as per Roche global guidance 2.Quality Procedures oSupport to release commercial product batches to the local market according to the local regulations and marketing authorizations. oSupport to ensure (Plan and execute) compliance with the relevant GxP guidelines and regulations for the products distributed / manufactured locally. oSupport, coordinate and manage local SOP process oSupport to evaluate all discrepancies from outsourced warehouse & distribution and approve corrective actions and review effectiveness of CAPAs as part of annual quality review 3.General (Mandatory): oAttend / complete all requisite on-line and F2F trainings (Role specific, Safety responsibility and Compliance) within specified time limit

Skills Required

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Job Detail

  • Job Id
  • Industry
    Not mentioned
  • Total Positions
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
  • Job Location
    Dubai, United Arab Emirates
  • Education
    Basic - Any Graduation
  • Experience
    2 - 6 Years Years