QA Document Reviewer

Apollo Health And Beauty Care; Toronto; On-site; CAD 80,000 - 100,000; Full time

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

Gym Access

Dental insurance

Health insurance

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

Attention to detail

Compliance knowledge

Statistical analysis

Computer literacy

Education

High school diploma or equivalent

Relevant certification

Job description

Overview

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!

Benefits

• Gym Access
• Dental insurance
• Health insurance

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, 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

Qualifications

• 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