Réviseur de données (Développement & Validation)

Responsibilities and Duties :

Ensures that all data generated conforms to the methods, the specifications, the SOPs and good laboratory practices.

• Reviews documentation generated by the analyst;
• Ensures that the laboratory notebook contains all steps and information inherent to the analysis;
• Ensures that the laboratory notebook complies with GMP standards and current SOPs;
• Ensures that spreadsheets, sequences, laboratory reports, and other documents present accurate information;
• Verifies the integration of chromatograms;
• Checks the usage logs of analytical instruments;
• Ensures that the performance verification of the instrument used is valid;
• Ensures that the results meet the specifications when available;
• Documents irregularities and verifies the content of validation reports and deviation sheets,
• Ensures the consistency of results considering the project history;
• Prepares documents (result files, summaries, etc.) and may send them to clients;
• Acts as a resource person, supports laboratory employees in performing their tasks such as writing investigation reports;
• Communicates and explains detected errors to the employee.

Engages in continuous improvement :

• Makes sure to communicate to all employees the basics of adequate documentation;
• Evaluates the quality of the projects submitted by the employee and provides a report to the supervisor;
• Participates in the standardization of revision within the department;
• Suggests ideas for improvement in order to minimize review time.

Skills, knowledge and abilities :

• Supports a workload with accuracy and within prescribed deadlines;
• Able to complete a given task within tight deadlines;
• Able to complete several concurrent projects;
• Handles frequent priority changes;
• Completes work with minimal supervision;
• Deals with lack of information, resolves minor issues independently;
• Plans and organizes time and work effectively;
• Sets priorities, develops action plans;
• Capable of interpretation;
• Identifies irregularities, makes relevant observations;
• Contributes to team functioning;
• Identifies development opportunities and provides improvement solutions, participates in improvements, is attentive to others, offers help and contribution, participates in peer problem-solving;
• Takes quick action in urgent situations;
• Able to establish contacts with others;
• Good listener, respectful, constructive in comments;
• Knowledge and proficiency in LabX, Empower, LIMS, Microsoft Office software;
• Knowledge of the pharmaceutical field, mastery of GLP regulations;
• Positive and professional attitude;
• Effective oral and written communication.
10 days ago