- BSc with 3+ years experience working in a pharma QA capacity
- Experience in CAPA, change control, investigations, etc.
- Ability to support weekly review of documentation
Quality Assurance Associate - PharmaHamilton, ON, Canada
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QUALITY ASSURANCE ASSOCIATE
The Quality Assurance Associate is a focused and motivated individual who helps to ensure GMP compliance during validation activities and routine production. This position will ensure that all regulated activities listed below are conducted in compliance with relevant regulations and internal procedures
• Responsible for QA activities associated with validation and supply; review of non-conformance reporting and investigations, follow up with CAPAs and change control activities and participation in quality audits (internal and external)
• Batch Record Review to release marketed and clinical products for uset
• Review SOPs, Batch Records, Test Methods and other controlled documents for compliance with regulations and propose changes for review and approval
• Review and approval of specifications for incoming raw materials and for finished products
• Review and Approval of equipment IQ/OQ/PQ and calibration/preventative maintenance documentation
• Review validation and stability protocols for compliance
• Review reports for compliance with protocols, quality system and regulatory requirements
• Support review of executed batch records and testing data, for compliance, including OOS, non-conformances, Change Controls and CAPAs
• Support vendor qualification program
• Assist in drafting and finalizing Annual Product Quality Reviews
• B.Sc or M.Sc in the life sciences with 1-5 years of experience in a GMP or equivalent regulated environment
• Training and experience in quality systems, quality audits, documentation, change control, CAPAs and review of quality records
• Strong understanding of Health Canada, FDA
Category: Biotechnology & Pharmaceutical
Reference ID: CA7677BM001372
Date Posted: 14/05/2019