QA Specialist
1 month ago
Assist in the development of a quality management system (QMS) that meets all regulatory (e.g., Health Canada and U.S. FDA) requirements.
- To maintain QMS documents and records in a centralized system.
- To handle on-site documents electronically, archiving, and records retention as per the company’s record retention period requirements.
- Review/verify quality and production records for completeness, accuracy, and adherence to Good Documentation Practices.
- Ensures compliance of records and timely accurate filing.
- To verify and perform revision control and management of documents distributed through the Company including but not limited to batch records.
- Ensures training records are up to date and compliant.
- Participate in FDA, Health Canada inspections, ISO Certification and surveillance, customer and internal audits. Responsible for rapid retrieval of records for audit purposes.
- Ensures that the operations are performed according to SOP.
- Initiates Non-conformance reports for significant deviations noted during daily Quality inspections.
- Facilitate the execution of Risk Management activities.
- Support new product development and production (e.g., Change Control implementation activities).
- Identify non-conformities and planned deviation process to oversee the execution of CAPA commitments.
- Assist in validation activities for new and existing products, process, and equipment and identify statistically-based sampling/testing plans for inspections and validations.
- To perform incoming raw material, and packaging material inspection and
- To assist in Laboratory testing.
- Identify and implement opportunities for continuous improvement.
- Performs other Quality Management System-related duties as required.
**Qualifications**:
- Bachelor’s degree (B.Sc.) in science or equivalent
- 1-2 years experience within a Quality Management System, and strong understanding of QA principles. Experience as Quality Assurance in Pharmaceutical/medical device industry is an asset
- Ability to work effectively independently as well as in a team environment managing
- Ability to work in a fast-paced environment.
- Excellent interpersonal, written and oral communication skills.
- Strong computer and organizational skills; working knowledge of MS Office.
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