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QA Document Reviewer
Job summary
A reputable healthcare company in Toronto seeks a meticulous QA Document Reviewer. You will audit production documents to ensure compliance with Good Documentation Practices and provide guidance to production staff. With 3-5 years of experience and knowledge of cGMP environments, this role is ideal for those passionate about quality assurance. Join our team for a challenging and rewarding career with benefits such as gym access and health insurance.
Benefits
Qualifications
- 3-5 years of experience in QA documentation.
- Knowledge of Good Documentation Practices (GDP).
- Experience in a cGMP environment is an asset.
Responsibilities
- Audit documentation for GDP compliance.
- Review production batch records for accuracy.
- Provide training and guidance to production personnel.
- Generate reports and maintain documentation systems.
Skills
Education
Were looking for a meticulous and detail-oriented QA Document Reviewer to join our team!
In this role, you will be responsible for auditing all production-related documents to ensure compliance with Good Documentation Practices (GDP) in accordance with current Good Manufacturing Practices (cGMP). Your keen eye for detail will help identify and correct non-conformances, ensuring the integrity and accuracy of our production documentation. If you have a passion for quality and compliance, wed love to hear from you!
- Gym Access
- Dental insurance
- Health insurance
- Audit on-line documentation practices to ensure GDP requirements are met & completed
- Review of production batch records for completeness and accuracy
- Interact with production personnel in educating them on correction, addition and completion of such records per applicable GMPs
- Provide guidance including on-line training to maintain process control when required.
- Review Statistical Process Control Charts (SPC), production Fill Sheets, Batch Sheets etc. ensuring complete Batch Record review - assuring that there are no errors; if errors or omissions have occurred, that they have been corrected appropriately.
- Ensure that all documentation meets cGMP Compliance.
- Issue and assign process of corrective action for rework.
- Generate reports as required, including statistical analysis based on documentation.
- Create and maintain an orderly filing system including hard copy and electronic databases for batch records, CofAs, etc.
- Adhere to all QA / QC and Company policies and procedures including health and safety.
- Follow procedures and wear required PPE per safety guidelines.
- Identify and report any hazard(s), accidents, and injuries requiring first aid, health care, lost-time injuries, occupational diseases or incidents in the workplace.
- Use equipment, materials and machinery only as authorized.
- Any other related duties as required
- 3-5 years of experience with a high school diploma or equivalent
- 2-3 years of experience with post-secondary education or relevant certification / license
- Previous experience in a cGMP environment is an asset
- Computer literacy is considered an asset
- Knowledge of Good Documentation Practices (GDP) and experience performing related audits
* The salary benchmark is based on the target salaries of market leaders in their relevant sectors. It is intended to serve as a guide to help Premium Members assess open positions and to help in salary negotiations. The salary benchmark is not provided directly by the company, which could be significantly higher or lower.
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