Job Title: Head/ Senior Manager
Location: Abu Dhabi, UAE
• Ensure compliance to
national/international regulatory requirements with current Good Laboratory
• Manage, plan and direct
the quality control and microbiology laboratories to ensure lab testing
provide the highest
quality analytical support to manufacturing while ensuring compliance with
protocols, cGMP and
• Direct the work
activities of the raw material, packaging materials, in-process and finished
and stability studies to
ensure that testing is executed in a timely and compliant manner.
• Review and investigate
all laboratory data that is out of trend and OOS.
• Review and approve
protocols and reports such as method validation, method transfer, process
validation and stability
• Report any risks to
compliance or product quality to Head of Quality.
• Participate in all OOS
investigation, identify root cause and implement corrective action.
• Review, assessment of
all change controls, deviations, CAPA that arise from quality control
• Ensure all SOP are
initiated, reviewed, approved and implemented as per the documented process.
• Participate Product
Quality Reviews, provide data and documentation for all products in
accordance with SOP.
• SOP, laboratory records
and other related documentation as assigned meeting the requirementsof data
integrity and governance.
• Proven experience as a
Quality Control Head/Sr. Manager role in biopharmaceutical/sterile
• 12+ years of experience
in regulated environment with about 5 years in managerial role with quality
• Excellent knowledge of quality
methodologies and standards.
• Excellent understanding of data
• Good knowledge of MS Office and
• Excellent communication skills, fluent
in English, both written and spoken.
• Good attention to detail and a result
• Good project management skills
• Bachelors or Masters in Pharmaceutical
Sciences / Analytical Chemistry/Biotechnology related
• Handled stringent regulatory audits
such as EU GMP, US FDA, GCC/SFDA.