Quality Assurance Associate
Job details
Introduction We are currently hiring aQuality Assurance Associate to for our client, a global pharmaceutical company known for its contribution in areas including pharmaceuticals and consumer healthcare products globally. This is a full-time contract with possibility of extension or become permanent. Responsibilities Quality Assurance Operations:
- Support the execution of quality assurance activities in alignment with GMP (Good Manufacturing Practices), regulatory requirements, and corporate standards.
- Review and approve production records, batch documentation, and certificates of analysis for product release.
- Conduct investigations for deviations, non-conformances, and CAPAs (Corrective and Preventive Actions) to ensure timely resolution and compliance.
- Collaborate with cross-functional teams to ensure adherence to regulatory and company quality policies.
- Participate in internal and external audits, including preparation, execution, and follow-up on corrective actions.
- Stay current with industry regulations, guidelines, and best practices to ensure compliance and continual improvement.
- Perform risk assessments and contribute to quality risk management plans for processes and products.
- Manage and update SOPs (Standard Operating Procedures), work instructions, and other controlled documents in the quality management system.
- Support quality improvement projects, including the optimization of QA processes and tools.
- Assist in training programs related to quality systems, regulatory updates, and best practices for internal teams.
- Bachelor’s degree in Life Sciences, Biochemistry, Microbiology, Chemistry, or related field.
- 2-5 years of experience in a QA or compliance role within the pharmaceutical, biotech, or healthcare industry.
- Strong understanding of GMP, Health Canada regulations, FDA guidelines, and ICH standards.
- Familiarity with quality management systems (e.g., TrackWise, Veeva Vault) is an asset.
- Proficiency in handling documentation, deviation management, and batch record review.
- Excellent organizational skills with the ability to prioritize tasks effectively.
- Strong communication and collaboration abilities to work within cross-functional teams.
- Analytical mindset and attention to detail for problem-solving and ensuring quality compliance.
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