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Student-quality Assurance

3 weeks ago

Brantford, Canada Apotex Pharmachem Inc. Full time

**About Apotex Inc.**

**Job Summary**:
Under the supervision of the QA Documentation Supervisor, the Student
- Quality Assurance will prepare and verify all test methods, specifications, related documentation/data and protocols to implement the LIMS system and related document repository.

**Responsibilities**:

- Through interaction with the LIMS implementation project team, develop a thorough understanding of requirements for documentation and data preparation, entry/upload & verification activities.
- Act as the lead for ensuring documentation readiness for the LIMS related documentation/data; create a project plan with defined milestones & timelines.
- Review analytical methods, specs and other related documentation for accuracy and completeness against master lists, to support right first time data/document collection.
- Create and/or update t work instructions or SOPs to reflect changes required for LIMS.
- Provide any other requested support to the LIMS implementation team as required for LIMS and related document repository implementation.
- Works in a safe manner collaborating as a team member to achieve all outcomes.
- Demonstrate Behaviours that exhibit our organizational Values: Collaboration, Courage, Perseverance, and Passion.
- Ensure personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies and procedures, Safety and Environment policies, and HR policies.
- All other relevant duties as assigned.

**Job Requirements**:

- Knowledge, Skills and Abilities
- Must be able to work independently and as part of a team.
- Demonstrated ability with Microsoft Word and Excel.
- Ability to follow Standard Operating Procedures (SOP).
- Experience working with LIMS and/or chemistry background an asset.
- Familiarity with Good Manufacturing Practices (GMP) an asset.
- Performs all work in support of our Corporate Values of Passion, Perseverance, Collaboration and Courage; Demonstrates strong and visible support of our values.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.

At Apotex, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported.

Apotex offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.