Document Reviewer, Formulation Development

About Apotex Inc.

Job Summary

Responsible for the review, and verification of all executed batch documents, associated forms and in-process testing reports. Ensures the completeness and accuracy of all batch documentation as per established Apotex and GMP standards.

Job Responsibilities
Review FD manufacturing and packaging documents to ensure quality products are manufactured and packed according to established standards and procedures. Ensure that batch records follow the established master formula. Verify yields/accountability are accurate and within the specifications.
During document review, ensure that all changes to master documents have been applied as per Q-notification or F-notification or where applicable, changes have been co-signed by R&D QA.
Notify the Supervisor / Manager, Form Dev New Products Ops of any deviations found during review of batch documents or associated forms.
Prepares summaries of deficiencies noted during review of documents and coordinates with FD Supervisors to ensure all corrections are made in the appropriate manner and ensure that all issues are fully explained and supported by the necessary paperwork.
Liaises regularly with Supervisors, Technicians, R&D QA and with Management, to be aligned with the business priorities and, to keep them current with the progress & findings of their Document-Review.
Trend documentation errors occurring in Manufacturing and Packaging records on monthly basis and provide report to Supervisors in FFD and Manager, Form Dev New Products Ops.
Prepares and presents Documentation-error-trends, as well as frequent errors, to the team of FD technicians, to bring awareness on good documentation practices.
In collaboration with FD Supervisors, attends to conventional queries of junior level and higher level technicians, providing information relative to their area of expertise, which is good documentation practices.
Review in-process testing results, where applicable, and ensures tests were performed according to the required procedures and that all results are within the established specifications (where applicable).
Record the receipt, and review of all batches in the FD Tracking Database.
Verify Q-notifications/ and F-notifications issued for the batches using SAP, and ensure that all are set to S&L status prior to forwarding to R&D QA for review / release.
Verify additional sampling/testing requirements have been completed as required by Project Plan or Stability Batch Protocol.
Complete required sections of documentation review checklist prior to sending the documents to R&D QA.
Responds to internal and external requests for information related to executed manufacturing documents.
Supports training of new hires.
Works as a member of a team to achieve all outcomes.
Performs all work in support of our Corporate Values of Collaboration, Courage, Perseverance and Passion.
Performs all work in accordance with all established regulatory and compliance and safety requirements.All other duties as assigned.
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
Community College Diploma/University degree (or equivalent) in a related discipline
Knowledge, Skills and Abilities
Demonstrated accuracy and attention to detail
Good command of the English language (both written and verbal)
Excellent organizational skills and the ability to manage time effectively
Ability to follow instructions according to written procedures
Ability to manage multiple priorities in a fast-paced and changing environment
Knowledge of GMP required
Experience using microcomputers, preferably Microsoft Office (Word, Excel, Access and Powerpoint).
Experience
Minimum 3-4 years experience 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.