Validation Coordinator

The Coordinator will perform validation activities for the processes, facilities, utilities, manufacturing, and laboratory equipment. Ensuring compliance with Health Canada/FDA/TGA regulations, Quality Management systems, Good Manufacturing Practices and 21 CFR Part 11 (Electronic Records and Signatures). Responsibilities will include the execution of validation protocols (IQ, OQ, PQ).

Responsibilities

Perform validation activities for the processes, facilities, utilities, manufacturing, and laboratory equipment; Ensure compliance with Health Canada/FDA/TGA regulations, Quality Management systems, Good Manufacturing Practices and 21 CFR Part 11 (Electronic Records and Signatures); Execute validation protocols (IQ, OQ, PQ); Maintain and operate equipment in a safe and efficient manner; Coordinate with other functional departments to develop and implement validation test plans; Prioritize validation activities according to compliance and business needs; Coordinate projects and schedules; Monitor progress of the validation master plan, procedures and strategies; Ensure validation efforts are conducted in an appropriate and timely manner; Interact with individuals from different disciplines (Production, Maintenance, Engineering, and Quality) to plan, execute and complete validation activities, including reports and corrective action items to ensure timely completion; Oversee validation testing for new products and process improvements; Review all key documents developed and executed by applicable personnel; Maintain all validation documents; Participate in and review all change controls (CC) and evaluate for revalidation activities; Adhere to Safety Policies (SPs), Goods Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs)

Requirements

Bachelors Degree in an appropriate science (Chemistry) or Engineering discipline; Validation experience or participation in validation work group activities (2+ years); GMP industry experience in pharmaceutical or dietary supplement manufacture of solid dosage forms, in a hands-on technical/analytical role; Good analytical laboratory skills; Ability to work with computers (specifically MS Office); Knowledgeable about data governance and integrity regulations

Nice to have

Familiarity with ISPE Baseline Guide 5 (Second Edition) (an asset)

Benefits

Great benefits (healthcare, health & personal spending accounts, wellness days, Employee & Family Assistance Program); $200.00 safety boot voucher & company provided PPE; $300.00 per year to spend on company products; Employee discount pricing; Employee appreciation events & rewards; Free onsite parking; Employee wellness sessions