Summary Execution of assigned tasks in the quality control laboratory in accordance with cGxP regulations. Performance of laboratory specific activities such as analyses, maintenance, calibration and qualification of analytical equipment.
Key Responsibilities:
Operational
Sample storage and management
Analytical testing and documentation of API / drug substance / drug product / finished product / Complaints / stability / packaging material samples
Ensure all activities in compliance with cGxP, incl. data integrity
Stability (when not centralized)
Testing/Sample storage and management
Analytical documentation of stability samples to cGxP standards
?HSE
Comply with all HSE guidelines
Detect and report potential accident, risks and propose solutions
Responsible for participating in initial training and retraining
Essential Requirement:
Preferred: Previous experience working in a laboratory environment in the pharmaceutical industry (quality assurance, production), aseptic technique.
Collaboration; result-oriented
Administrative activities and GMP and HSE-compliant, efficient production and documentation of standardized tasks in the infrastructure
Breakthrough Analysis; Being Resilient; Operational Excellence; Continuous Learning; Digital & Tech Savvy
Laboratory equipment; Quality Control (QC) Testing; Quality Control Sampling; knowledge of TQM and related industry GxP standards and processes; Laboratory Excellence; Quality decision making
Must be willing to work in 12hrs rotational shift.
Desirable Requirement:
Completed apprenticeship as a laboratory assistant or equivalent training
Basic (oral and written) in English; fluent in local language (oral and written)
Skills Desired Continued Learning, Dealing With Ambiguity, Decision Making Skills, Gxp, Industry Standards, Laboratory Equipment, Laboratory Excellence, Quality Control (Qc) Testing, Quality Control Sampling, Self-Awareness, Technological Expertise, Total Quality Management
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