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Laboratory Specialist
3 weeks ago
Our team is responsible for managing the storage and inventory of laboratory samples, conducting analytical testing and documentation for APIs, drug substances/products, complaints, packaging materials, and stability samples.
We ensure strict compliance with cGxP standards, including data integrity requirements. Our roles also involve executing and documenting stability testing (if not centralized), following all Health, Safety, and Environment (HSE) guidelines, identifying and reporting safety risks or potential incidents, proposing preventive solutions, participating in mandatory training and retraining programs, and supporting operations during rotating day/night shifts.
Role RequirementsEssential Qualifications and ExperiencePrior experience in a laboratory setting within the pharmaceutical industry (QA, production), preferably with exposure to aseptic techniques, is highly valued. Proficiency in administrative and documentation tasks compliant with GMP and HSE standards is also required.
- Breakthrough analysis and problem-solving skills are essential for success in this role.
- Resilience and adaptability are crucial in our fast-paced environment.
- Operational efficiency and continuous learning are key components of our company culture.
- Digital fluency and technical skills are necessary for effective collaboration with our team members.
Hands-on knowledge of laboratory instruments and QC testing procedures, as well as a strong command of GxP, TQM principles, and lab excellence standards, are expected. The ability to maintain QC IPC/DS laboratory equipment and systems in accordance with cGMP compliance is also required. Additionally, competent execution of product testing within timelines and contribution to validation and method development are essential responsibilities of this role.