- BSc with 1+ year experience in a GMP environment
- Experience in QA activities supporting production of product
- Experience using SAP or other systems an asset
- Analyzes reviews and approves all executed manufacturing and packaging batch records for compliance to regulatory specifications, customer requirements, and internal cGMP procedures and systems. Assembles all batch records to ensure all the documents required for product release are present. Follows up to obtain any missing documentation.
- Compiles appropriate batch record documentation and sends copies of completed sets to the customer for release of the finished product as required.
- Reviews and approves laboratory results for purified water, bulk product and finished product to support final release for shipment.
- Generates and approves product Certificate of Analysis (COA) or Certificate of Conformance (COC) as required. Scans completed documents for electronic filing.
- Approves release of batches based on review of successfully executed batch records.
- Establishes bulk and finished products are released in a timely manner to meet customer requirements.
- Follows up on laboratory testing results to ensure testing is completed by the scheduled completion date.
- Contribute to achieving Lean Goals and continuous improvement.
- Bachelor of Science, with a minimum of 3 years of pharmaceutical manufacturing experience.
- Knowledge of cGMP requirements for pharmaceutical manufacturing.
- Knowledge of computer systems such as SAP and Microsoft Office Excel is an asset
- High attention to detail in reviewing documents for accuracy and compliance to specifications.
- Flexible with the ability to adapt, respond quickly and manage change in a fast paced environment.
Quality Assurance Associate - Production - ContractMississauga, ON, Canada
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QUALITY ASSURANCE ASSOCIATE - PRODUCTION - CONTRACT
Category: Biotechnology & Pharmaceutical
Reference ID: CA7677BM001366
Date Posted: 09/05/2019