Pharmaceutical Validation Associate (closed)
Pharmaceutical Validation Associate
•Prepare commissioning documents (e.g. FAT and SAT) and/or qualification protocols (e.g., IQ, OQ, PQ) for computer system, equipment, process or utilities validations.
•May participate in pre- and post-execution activities of commissioning and/or qualification protocols.
•Prepares qualification documents for computer validation including, but not limited to, validation plans, user requirements specifications, functional specifications, system design specification and other documentation as prescribed in the Bio-Pharmaceutical Good Automated Manufacturing Practices.
•Provides support to customers and internal team with documentation management of executed documents.
•Prepares commissioning documents for commercial-based projects (for example, data centres)
Knowledge, Skills & Abilities
Sufficient formal education and/or experience in a related field to gain an understanding of:
•Pharmaceutical processes, cGMP principles, documentation practices and validation requirements including but not limited to software, hardware and electronic records.
•Knowledge of Building Automation Systems would be very beneficial.
•Knowledge of engineering fundamentals, HVAC concepts and operations would be beneficial.
Must have strong verbal and written communication, personal computer, project management, and organizational skills.
Must be able to work from the Brampton branch office and from various client sites locations on a full time basis.
2-4 years of validation experience and/or related formal education