We’re 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, we’d love to hear from you!JOB RESPONSIBILITIES
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, CofA’s, 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
JOB REQUIREMENTS
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
