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Quality Control Technician Stability
Ensures the management of stability samples in accordance with established procedures and protocols.
Prepares stability results related to the preparation of all Annual Reviews (AR) and Product Annual Reviews (APR).
Assists the stability analyst with tasks related to the stability department.
COORDINATION OF STABILITY SAMPLES AND RESULTS
Receives labels and incubates stability samples.
Manages the storage of samples.
Prepares the monthly list of samples.
Performs the monthly sample withdrawals.
Ensures proper organization and cleanliness of stability chambers and incubators.
Disposes of samples when required.
STABILITY RESULTS
Records enters and approves results in various LIMS stability systems.
Reviews stability files.
Ensures that obtained results are within product trends and reports any anomalies.
Files analytical records and archives documentation.
Responsible for preparing all required stability results for ARs and APRs within the required timelines.
ASSISTS THE STABILITY ANALYST
Acts as the stability analysts delegate when required.
Assists the stability analyst in investigations deviations and incidents related to the stability department.
Supports the stability analyst in any other tasks related to stability activities.
No budget to manage. Any expenses to be incurred are under the responsibility of the department head.
a) Education
Technical diploma or bachelors degree in Chemistry or related sciences or an equivalent combination of education and experience.
b) Languages
French required and English an asset
c) Specific Experience and Knowledge
(Not specified)
d) Specific Technical Skills
Ability to work in both official languages.
Knowledge of GMP regulations (Health Canada FDA European standards).
Document management.
Knowledge of SQL and LIMS Stability considered an asset.
e) Knowledge and Abilities
Attention to detail and thoroughness in managing files and data.
Strong organizational skills autonomy and ability to manage priorities.
Team spirit and collaboration.
Ability to manage multiple files simultaneously.
Flexibility and adaptability.
Capacity to handle ambiguity.
We are an Equal Opportunity Employer. We are committed to building diverse teams representative of the patients and communities we serve and we strive to create an inclusive workplace that cultivates collaboration.
Required Experience:
IC
Learn about Bausch Health, a global company whose mission is to improve people’s lives with our health care products.