Personnel handling this profile will be responsible for performing reactions as per the requirement of the project. They are also responsible for documenting the observations in relevant note books. They are to follow instructions from the supervisor and work in a group (or individually) to accomplish the tasks in a timely and efficient manner.
Ensure process is in place to maintain the PV QD Training Matrix, training curriculum updated. Ensure global traceability and monitoring of investigations of all identified quality gaps, quality risks and ensure that Corrective and preventive Action Plans are implemented in timely manner.
The Quality Manager responsible for handling technical complaints is tasked with investigating and managing technical complaints raised by clinical investigator sites regarding Investigational Medicinal Products and Medical Devices.
Support data integrity incidents, manage escalations, and contribute to global DI networks and initiatives.
Familiarity with institutional requirements for animal use and welfare in pharmacology experiments is essential. Additionally, you will effectively communicate the goals, protocols, and results, contribute to regulatory submissions, and foster cross-team collaboration to enhance IMA research innovation and decision-making processes.
Work with the Team to achieve and exceed targets within the frame given by the Group Leader and Team Leader of Process Innovation. Keep self updated on the state of the art in synthetic chemistry development and techniques, while putting specific focus on innovative process research
Plan, implement and evaluate experiments for establishing of composition, manufacturing procedures and packaging via support of def. evaluation experiments taking product stability, bioequivalence and possible production site into consideration.
Must have Injectable Experience, and Knowledge of Aseptic Area, Autoclave, Filling, QMS, washing and sealing and Batch Manufacturing or fresher also apply. Must have Injectable Experience, and Knowledge of Aseptic Area, Autoclave, Filling, QMS, washing and sealing and Batch Manufacturing.
Able to conceptualize and design novel vectors across expression systems including bacterial, yeast, mammalian, gene modification techniques. Experience in mass spectrometry for protein, antibody analysis.