QA Sr. Specialist (Sterile Area)
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.
As QA Senior Specialist your focus will be on the sterile production area, and you will be responsible for monitoring the manufacturing and packaging process to ensure the agreement with GMP procedures and report any violations during the manufacturing activities. The position reports to QASenior Section Head of the sterile area and the location are based in our Cairo site in Al Obour City.
Your responsibilities:
- Monitor production processes against batch records to ensure GMP compliance and prevent deviations.
- Enter manufacturing and expiry dates for the monthly ampoule plan in SAP.
- Review and approve monthly ampoule films for printing.
- Collect and review batch record documents for market release, record data in annual product review template.
- Report violations to the compliance team, ensure root causes are identified, and corrective actions implemented.
- Participate in annual quality self-inspection plans to detect and address deviations in manufacturing practices.
Qualification and Experience:
- Bachelor’s degree of pharmacy or science (Chemistry)
- Work experience: 2-5 years
- Decision-making and problem-solving skills
- Ability to handle stress effectively
- Excellent English proficiency and communication skills
- Highly detail-oriented
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!