Analyste principal - Développement Analytique

Under moderate supervision and in collaboration with a team, the holder of this position participates in analytical activities related to the development project :

• Performs analyses on samples of raw materials, excipients, in-process products, and finished products using methods, techniques, analytical equipment, and according to pre-established specifications.
• Conducts development, pre-validation, validation, and verification of analytical methods for raw materials, excipients, in-process products, finished products, and cleaning verification (residues) using methods, techniques, analytical equipment, and according to pre-established limits and specifications.
• Writes various analytical reports.
• Collaborates in implementing action plans to investigate any discrepancies between the targeted result and the obtained result.
• Responsible for problem-solving during the execution of analytical tasks related to their responsibility.

Responsible for certain related tasks to ensure the functional handling of the laboratory under GMP conditions.

RESPONSIBILITIES & DUTIES :

• Conduct physical tests.
• Conduct physico-chemical tests.
• Perform qualitative and quantitative chemical analyses.
• Ensure the use of current versions of specifications and methods.
• Program and operate current data acquisition systems.
• Share observations with the immediate supervisor and all appropriate persons clearly and precisely to suggest improvement ideas and create a cooperative climate.
• Report any discrepancies between the targeted result and the obtained result.
• Conduct complex analyses : unstable solutions, detection with refractive index or MS, derivatization, difficult extractions.
• Complex techniques : e.g., UHPLC, Conductivity Detector (Dionex), ICP.
• Perform gas chromatography.
• Write or review analytical and scientific documents (e.g., analytical methods, reports, etc.).
• Write standard operating procedures (SOPs).
• Under the supervisor’s responsibility, assist and train Analysts on specific techniques.
• Ensure relevant training is completed before performing a task.
• Under the supervisor’s responsibility, participate in writing, expertise, and follow-up on actions for controlled changes, deviations, and corrective and preventive actions (CC, REQ, CAPA).
• Collaborate in implementing action plans to investigate any discrepancies between the targeted result and the obtained result.
• Ensure that the requirements of allocated related tasks are met on time.
• Participate in the continuous improvement program using available tools.
• Ensure full compliance with Good Laboratory Practice guidelines.

Skills, knowledge & aptitudes :

• Agility
• Strong result and customer orientation
• Ability to communicate openly, clearly and transparently at all levels, both orally and in writing
• Collaboration and openness to decisions
• Exemplary character, positive and committed attitude - motivated by the company's mission and values
• Accountability for facts and actions
• Knowledge of current laboratory technologies
• Knowledge of Good Laboratory Practice (GLP) guidelines
• Proficiency in the use of Empower (Waters), Microsoft World and Excel software.
• Ability to analyze problems
• Effective and efficient planning and organization
• Knowledge of the pharmaceutical industry
5 hours ago