Chemist, Qc

**About Apotex Inc.**

**Job Summary**:
Responsible for generating accurate results while following GMP requirements. Responsible for analysing laboratory samples using various chemical and instrumental techniques, in accordance with established compendial and in-house testing methods, while working under mínimal supervision. If required, responsible to review documentation for the QC department.

**Responsibilities**:

- Performs analysis of all laboratory samples including raw material, in-process, finished products, purified water, process, method and cleaning validation and stability samples using analytical instruments and established analytical procedures and techniques.
- Prepares test samples and sets up and operates various laboratory instrumentation.
- Performs analyses associated with method transfer and/or method verification.
- Documents, interprets, and compiles all observations and data obtained from testing as per established SOPs and good documentation practices.
- Recognises OOS or out of trend results and completes lab investigations under minimum supervision. Promptly notifies Supervisor of any observations or results, which may impact on the validity of data and/or reflect variability in the manufacturing process where applicable.
- Performs general maintenance and calibration of laboratory equipment as required by the department's established calibration program and GMP requirements.
- Troubleshoots instrumentation and method problems, recommends solutions and works collaboratively with Supervisor to resolution.
- Utilizes technical expertise to troubleshoot on more complex, problematic products.
- Performs all work in accordance with all established regulatory and compliance and safety requirements.
- Disposes of waste solvents and orders any chemicals or laboratory supplies as required.
- Performs role of document reviewer as outlined below:

- Reviews electronic and/or paper data associated with a specific analysis and signs off on the completed QC reports.
- Ensures accurate results that conform to current specifications, according to Good Manufacturing Practices, in house, compendial and regulatory requirements, and verifies all calculations for mathematical and analytical accuracy.
- Consults with Supervisor on any issues of non-conformance.
- Reviews calibration of instruments, as assigned, to ensure accuracy and precision in the performance of laboratory equipment.
- Reviews third party documentation, method transfer projects and supplier certificate of analysis, as applicable, to ensure completeness and accuracy of reporting.
- Liaises with department Chemists to ensure that all necessary corrections are made to analytical reports and document requirements to ensure compliance to GMPs.
- Performs additional related duties, as assigned, including the tasks of a Chemist, QC QS4 and Chemist QC QS5.
- Works as a member of a team to achieve all outcomes.
- Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence; Demonstrates strong and visible support of our values.
- Performs all work in accordance with all established regulatory and compliance and safety requirements. All other duties as assigned.

**Job Requirements**:

- B.Sc. from a recognized educational institution in Chemistry or a related field and a minimum of 2 years relevant experience in a pharmaceutical lab or equivalent; OR Community College diploma in a related field and preferably 3-5 years relevant experience in a pharmaceutical lab or equivalent.
- Knowledge of Excel, Word and other Microsoft Office Programs and/or laboratory software packages.
- Strong working and theoretical knowledge of automated laboratory instrumentation such as HPLC, AA, UV, Dissolution, IR, UV/VIS spectrophotometry and GC.
- Ability to interpret results and perform work with mínimal supervision.
- Detail oriented with excellent problem solving and instrument troubleshooting ability.
- Excellent verbal and written English communication skills.
- Excellent interpersonal skills.
- Excellent knowledge and understanding of GMP/GLP as applied to a laboratory setting.
- Proven organization and time management skills as demonstrated through previous work and/or educational experience.

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.