Technician Qc

Job Summary (Primary function)

During the construction and QC laboratory startup phase, the QC technician will participate to equipment setting up. This person will also participate to the documentation preparation linked to QC activities. For the first project phase, the QC technician will be in charge of the utilities and environmental monitoring sampling, raw material testing, and in the second phase, will participate to the analytical transfer for chemical or biological methods.

During manufacturing operation, the QC technician will perform the QC analysis to support production and release of drug substance. The team will be multi-purpose and the QC technician will need to perform a large panel of analyses.

Essential Functions of the Job (Key responsibilities)

During the construction phase, you will mainly:

- Author comprehensive work instructions
- Initiate deviations, and participate to create any corrective or preventive actions
- Participate to the change requests initiation
- Prepare and deliver training to new members of the team
- Participate to the environmental monitoring and utilities qualification
- Participate to the Raw material testing
- Participate in the test method tech transfer

During operational phase, you will mainly:

- Perform the QC analysis to support production and release of drug substance and perform a large panel of analyses
- Author, review and maintain (lifecycle etc.) of all required Standard Operating Procedures, Work Instructions, and other quality documents related to areas of responsibility, as well as support other areas as required
- Ensure that the analysis are done on time with the appropriate quality
- Raise deviations and participate to some investigations
- Participate to the change requests initiation
- Contribute positively to a strong culture of business integrity and ethics
- Act within compliance and legal requirements as well as within company guidelines

Qualifications (Minimal acceptable level of education, work experience, and competency)
- CFC or BTS with at least 2 years’ experience in the biotech, pharmaceutical or chemical environment
- Hands-on experience in a GMP environnement
- Follow the security rules required to work in a laboratory
- Ability to work in a fast paced - high regulated environment
- French with a good level in English
- Team work oriented mindset
- Shift work is expected

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

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