Quality Software Specialist
Bausch Health Canada is the international head office of Bausch Health Companies, one of the fastest growing international pharmaceutical companies dedicated to bringing quality health and wellness products to all Canadians. Our team manufactures and markets a wide variety of pharmaceutical and health products that are distributed in pharmacies, healthcare practices and hospitals across the country. At Bausch Health, we invest in our employees and we believe in the importance of cultivating performance and outdoing ourselves in finding new and better solutions with the aim of responding innovatively and effectively to current needs. Objectives: Responsible for developing, implementing, maintaining and training on state of the art laboratory information management systems and other data systems required by the laboratory. Ensure that all GMP/CLP/GAMP/FDA/CH compliances are met. Key Activities/Responsibilities: 1. Act as system administrator for local laboratory network and continuously monitor and maintain the status of laboratory computer systems and instruments (hardware, software, and communication, back-ups) to minimize downtime and improve reliability. Create, modify, remove user accounts on lab applications. Perform system user access review and audit trail review. 2. Continually develop, implement, maintain and train on laboratory computer system upgrades to ensure laboratory in compliance with federal regulations such as 21 CFR Part 11. 3. Act as project manager and work with SQA and IT departments to ensure smooth project transition. 4. Prepare system validation documents and reports to facilitate proper validation, requalification and implementation of legacy and new instrumentation in the laboratory. Perform Empower custom field validation. 5. Train chemistry staff to maintain high level of awareness and focus, particularly when changes are planned and/or occur with respect to software upgrades/enhancements. Provide continual software support to chemistry staff to ensure efficiency and adherence to compliance requirements. 6. Continually create and update system SOPs and back-up/archive procedures in accordance with regulatory requirements outlined in CFR. 7. Identify, evaluate and plan new hardware and software technologies to improve laboratory productivity and efficiency in line with facility/corporate objectives. 8. Perform document changes and change requests (quality and IT). Scope of position: Act as system administrator for local laboratory network and continuously monitor and maintain the status of laboratory computer systems and instruments (hardware, software, and communication, back-ups) to minimize downtime and improve reliability. Qualifications/Training: – BS Chemistry and BS Biotechnology – Technical expert in laboratory instruments and computer systems. – Waters System administration and advanced software. – LabVantage – Sapphire-GLIMS – 5 years Pharmaceutical experience. The masculine is used in this publication without prejudice for the sake of conciseness. Bausch Health is committed to equal employment opportunity and complies with equal employment opportunity laws in effect wherever it operates. Link: https://career2.successfactors.eu/sfcareer/jobreqcareer?jobId=2806&company=Bausch
