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Specialist QA Reviewer

3 weeks ago

Montroyal, Canada Pharmascience Inc. Full time

The Specialist QA Reviewer is responsible of the quality activities relative to authorize product release for sale or submission based upon review and approval of documents.

**Responsibilities**:

- Revise the documentation related to the release of a batch.
- Approve or reject a batch and change the status in SAP.
- Issue certificates
- Review the Change Controls related to the MBR changes.
- Review and approve the Bill of Materials BOM.
- Coordinate the QA requests between clients and PMS (which includes):

- Identify the clients’ requests and priorities and make the follow ups.
- Manage and communicate the priorities for sending documentation.
- Coordinate the transmission of required product launch documents.
- Review and approve the client specifications for Private Brand OTC products.
- Responsible for the inspection, revision et release of printed material, and the QA approval of the artworks (which includes):

- The file verification, release and blocked status in SAP, and the classifying of the files.
- Send the release certificates to clients.
- Approve change controls related to artworks (changes and creation).
- Sign TVS registers.
- Perform follow ups from returns to the clients.
- Send complaint letter to the suppliers when non-compliance events.

**Skills, knowledge and abilities**:

- Fluent in English & French (oral & written)
- Facility to interact and excellent aptitude to communicate with people
- Analytical skills and ability to summarize vast amounts of data
- Rigor and thorough
- Problem-solving skills
- Ability to make decisions
- Planning and organizational skills
- Capacity to adapt
- Competence with MS Office
- Good knowledge of the practical aspects of manufacturing, quality control and quality assurance in the pharmaceutical industry

**Experience**: Required
- 3 year(s): Experience in pharmaceutical industry or related sector

**Education**: Required
- Bachelor or better in Science or related field