Reports to: Lead Mechanic Responsibilities: Ensures all equipment is maintained in good working order. Timely set-up & readiness of equipment to support production schedule. Performs & maintains Production PM records in accordance wit...
Reports to: Manager of Regulatory Affairs Responsibilities: Assist the Manager of Regulatory Affairs during cGMP, Environmental, and Regulatory audits. With the assistance of Head of R&D (or designee), create and collate product master...
Reports to: Quality Assurance Supervisor or Manager Responsibilities: Conducts Annual Drug (Product) Reviews and Device History Reviews. Maintains Regulatory Compliance documents and documents of external origin. Maintain Document ...
Conduct non conformance, product complaints, out-of-specification investigation and provide corrective and preventive actions with follow-ups. Trains and supervises document review personnel; batch release personnel, Maintains accurate rec...
Responsibilities Assist the Manager during cGMP, Environmental, and Regulatory audits. Assist the Manager to create and collate product master files (dossiers), drug master files (DMF). Generate and Review of CoCs, CoAs, CoMs, BSE docum...