Steinbach, CAN
1 day ago
Quality Assurance Reviewer- 15 Months Term
Join a team! We are a global diversified pharmaceutical company enriching lives through our relentless drive to deliver better health outcomes. We develop, manufacture and market a range of products, primarily in gastroenterology, hepatology, neurology, dermatology, medical aesthetic devices, international pharmaceuticals. Our 7,000 employees share a common goal and values, propelling us to provide essential care to millions of people globally. We seek dedicated individuals who share our sense of urgency, unity, and excellence. We are looking for a trustworthy and respectful individual who consistently does the right thing. Someone who is imaginative and proactive, with a keen eye for what is possible. A perceptive and adaptive person who is action oriented. We need a disciplined, focused, and accountable team member. If you embody these values, come join our company and help us shape the future. We are all in it together to make a difference. Be a part of a culture that doesn't just wait for change but actively creates itwhere your skills and values drive our collective progress and impact. **ROLE TITLE:** **QUALITY ASSURANCE REVIEWER** **DEPARTMENT:** **QUALITY ASSURANCE** **REPORTS TO:** **SUPERVISOR, QUALITY ASSURANCE REVIEW** **SHIFT:** **SUNRISE 23:30 -08:00** Reporting to the Supervisor, Quality Assurance Review for the Steinbach site this position is responsible for Quality Assurance review and evaluation of various types of GMP documentation to determine disposition of in-process materials, bulk materials, and packaged product for Pharmaceutical and Natural Health Products. Maintenance of various Quality Systems to ensure regulatory compliance, in addition to supporting Lean initiatives and adherence to Key Performance Indicators. **Responsibilities:** + Review and evaluation of GMP documentation to determine disposition of in-process material, bulk material, and packaged products. + Resolve errors and/or discrepancies in collaboration with other operational areas in a timely manner ensuring appropriate action is taken and escalate to Supervisor and/or Manager as applicable. + Review, evaluation, and maintenance of various Quality Systems (Nonconformance Report, Initial Contact) including compilation of department metrics according to Key Performance Indicators. + Review, evaluate and assess impact of Nonconformance Reports, electronic audit trails, trending data and Initial Contacts. + Write and revise Standard Operating Procedures to ensure compliance. + Compilation of Annual Product Quality Review information on various Quality Systems. + Support the management of Contract Manufacturing Operations to ensure CMOs follow approved Quality Agreements, SOPs, and Regulations. + Support Regulatory Inspections and Audits. + Support Lean Initiates and 5 S Principles. + Ensure compliance to current Good Manufacturing Practices, Regulatory Requirements, and Occupational Health & Safety. **Education and Experience:** + Bachelor's degree in Science. + Minimum of three years’ experience in quality assurance or a regulated environment. + Documentation management including experience with electronic quality management systems. + Working knowledge of the associated regulations that govern the pharmaceutical and natural health products industries. **Required competencies/Abilities-** _Additionally, successful candidates will demonstrate:_ + A strong solution focus and high attention to details to identify problems and drive for results. + Excellent time management skills with a proven ability to meet deadlines and commitments. + Sense of urgency and flexibility. + Good verbal and written communication skills. + Proficient with Microsoft Office Suite, GLIMS and SAP. **Why Bausch Health?** Bausch Health is a dynamic, growing company with a dedicated team committed to excellence and to helping Canadians by providing them with important, high-quality healthcare solutions. It is a progressive, exciting place to work where opportunities abound for current and new employees to help make a difference for Canadians. We strongly believe the success of Bausch Health coincides with the achievement of personal and professional goals. We are a progressive, exciting place to work – where opportunities abound for new and current employees. Our team members work in a dynamic environment where professional and personal growth is encouraged. You have the satisfaction of knowing that you are working with dedicated individuals who share a common vision of innovation and an unrelenting focus on improving people’s lives with our health care products. Bausch Health accomplishes its commitment to diversity and inclusiveness by simultaneously nurturing the diversity of thinking, ideas and outlook that already exists among our employees. Through consistent and aggressive efforts, we attract, develop and retain talented people with a variety of perspectives from all backgrounds and cultures. Working in an environment that enables them to apply their collective talents to our shared principles and commitments will enable us to deliver the greatest value to our customers and the patients we serve. By cultivating a winning attitude, we empower employees to seize opportunities that support the company’s mission to improve people’s lives. _What we have to offer our employees in our state-of-the-art Steinbach manufacturing site:_ + Insurance coverage (Medical – Dental – Vision ) + Employee Assistance Program (EAP) + Gym on site + INSPIRE: Employee Recognition Program + Full-service Cafeteria - Free coffee & tea + Free parking _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._ Bausch Health is an EEO/AA employer M/F/D/V.
Confirm your E-mail: Send Email