Technician, QAip Packaging

1 week ago

Etobicoke, Canada Apotex Full time

About Apotex Inc.

Job Summary

Responsible for on line review of batch documents and the inspection and physical testing on samples of packaged finished goods, to ensure that the in process products conform to established standards and regulatory requirements.

Job Responsibilities
Ensure that individual work is performed and the Packaging department is operating in full compliance with GMP, SOD and established safety standards.
Perform on-line batch document review for the applicable sections as per checklist.
Notify QAIP and packaging personnel of any deviations found during the review of the in process batch documents. Ensure all corrections are made in the appropriate manner.
Review in-process testing results and ensure tests were performed according to the required procedures and that all results are within the established specifications.
Review in-process test results for completeness and provide immediate feedback to packaging technicians.
Perform packaging line clearance per established procedures.
Perform in process testing/inspection where required.
Perform annual inspection of reserve samples and complete documentation according to established procedures.
Collect laboratory, stability, and reserve samples, as required.
Perform sampling, inspection and physical testing on in process/ investigational samples according to SOPs (if applicable).
Report all deviations encountered during sampling and testing processes to the department Supervisor.
Review logbooks for completeness and provide feedback to Packaging personnel, where applicable
Assist packaging personnel with troubleshooting / investigation issues as required.
Perform daily balance calibration.
Where required, ensure equipment is calibrated before the calibration expiry according to established SOPs, and ensure that all results are properly documented and all calibration dates are current.
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
Education

A college diploma/university degree in Pharmaceutical Technology/ Chemistry or related sciences

Knowledge, Skills and Abilities

A good command of the English language, both written and verbal

Ability to follow instructions according to written procedures

Very good interpersonal skills required

A knowledge of GMP is an asset

Ability to work shifts when required

Familiarity with Word, Excel, Access is an asset

Experience

A minimum of two years of experiences in a pharmaceutical and/or production environment

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.

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