Biotechnologist- QA Specialist

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A leading pharmaceutical company in the UAE is looking for a Biotechnologist- QA Specialist with the following:

Job Responsibilites

  • Conduct in-process quality checks during production and packaging as per SOPs, recording results in batch records
  • Ensure cGMP compliance across biotech manufacturing areas by monitoring:
    • Documentation practices
    • Accuracy of batch records, logbooks, labels, etc.
    • Proper gowning, cleanliness, and adherence to SOPs and production instructions
  • Review batch manufacturing and packaging records for batch release approval.
  • Perform and verify line clearance and line release activities in line with SOP requirements
  • Prepare and maintain the Annual Product Quality Review (APQR) for biotech plants
  • Support the Site QA Lead in conducting product quality investigations and risk assessments
  • Participate in Change Control and CAPA (Corrective and Preventive Actions) assessments related to biotech products and facilities
  • Review and evaluate technical department SOPs and documentation for procedural adequacy.
  • Conduct regular site inspections, monitor self-inspections, and track CAPA compliance following GMP audits.
  • Ensure compliance across end-to-end QA activities in biotech manufacturing.
  • Promote a safe and healthy work environment by adhering to internal standards and regulatory requirements.
  • Execute additional QA tasks as assigned by QA leadership.

Job Qualifications

  • Bachelor’s or Master’s degree in Science Biotech
  • Minimum 3–4 years of experience in QA within biotech manufacturing or pharmaceutical distributors.
  • Strong working knowledge of cGMP standards and regulatory requirements of the pharma sector.
  • Excellent command of English (verbal and written)
  • Proficiency in QA software systems such as Agile, TrackWise, and AmpleLogic.
  • Strong risk assessment and quality decision-making skills
  • Good computer literacy and technical documentation abilities.

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