Quality Control Sr. Specialist (IRM / IPM)

Arcera is a global life sciences company headquartered in Abu Dhabi, United Arab Emirates. Our purpose is to enable longer and healthier lives while creating sustainable growth. We develop, manufacture, and commercialize a broad range of high-quality innovative and proven medicines in key international markets. With an operational footprint spanning over 90 countries across four continents, and manufacturing sites in eight countries, we offer more than 2,000 medicines across various therapeutic areas worldwide.

The job holder will be responsible for the timely and compliant physical and chemical testing of incoming raw materials (APIs and excipients), packaging materials and purified water to support production plan completion. In addition to leading or supporting investigations, supporting method transfer or validation and may help in training junior analysts. Position is a full-time on-site job and reporting to QC Section Head.

Location: our manufacturing site in Al Obour City, Cairo, Egypt.

Your Resposnsibilities:

• Analytical Execution: Performs compendial and in-house testing using both classical chemistry and instrumental analysis methods. 

• Review RM incoming lots’ manufacturer CoAs and specifications to ensure compliance with current pharmacopeial monographs before starting analysis. 

• Data Integrity: Documents all analytical steps, raw data, and calculations contemporaneously in analytical worksheets, logbooks or Laboratory Information Management Systems (LIMS) and SAP according to ALCOA+ principles. 

• Instrument and glassware Verification: Performs internal calibrations and routine verifications of laboratory equipment and glassware
  in accordance with approved procedures and calibration schedules, to ensure instrument and glassware suitability. 

• Monitor environmental conditions in the lab and retained samples room through following up data loggers readings. 

• Compliance: Strictly adheres to current Good Manufacturing Practices (cGMP), internal Standard Operating Procedures (SOPs), and relevant pharmacopeial monographs (USP, EP, BP) 

• Lead or support OOS, investigations, root cause analysis, CAPA actions and participate in risk assessments. 

• Training and on-boarding of junior specialists and trainees. 

• Support audits and inspections. 

• Method transfer & validation: Drafts protocols and execution plans for analytical method verification, and compendial method transfer when new raw materials or updated pharmacopeial standards are introduced. 

• Create and update SOPs and Wis 

• Promote laboratory safety and compliance with EHS requirements 

• Prepare and standardize laboratory reagents and volumetric solutions
  in addition to review and monitor reagents validity, expiration dates, re-standardization schedules, and storage conditions. 

• Share in preparation of annual purchasing plan for reagents and tools required for analysis of
  raw and packaging materials. 

• Support other QC departments, giving hands for finished products release and stability backlog.

Qualification and Experience:

• Bachelor's degree of pharmacy or science (Chemistry) 
• 5 to 8 years' of experience 
• Analytical Chemistry & Instrumental Analysis
• GMP / Regulatory Compliance
• Data Integrity (ALCOA+)
• Investigation & Root Cause Analysis
• Attention to Detail

 This is the opportunity to join a very dynamic organization, where decisions are taken fast and where you can actively participate in shaping our future. If this sounds exciting, we would love to hear more about you!