Provide direct validation quality support (e.g. compliance, regulatory assessment, validation) to the business unit, clients and corporate management.
Provide direct validation quality support (e.g. compliance, regulatory assessment, validation) to the business unit, clients and corporate management. For laboratory validation and revalidation activities/projects with low to moderate complexity, perform quality functions to ensure accurate and timely completion with frequent decision-making. Create, review, approve, track and present documents/reports required for compliance with pharmaceutical regulations and identify areas of non-compliance and assist in the resolution of major issues. Perform activities across key quality functions as needed to ensure full support of business units. Analyze data for routine validation and production documentation to identify critical production and system processes, acceptability of data results, identify deviations and work with supervision to resolve. Approve routine validation and production documentation. Maintain and use database systems. Perform GMP audits and quality engineering activities related to process improvement. Prepare, retrieve and review documentation for customer and regulatory audits. Assist with presentation of data during customer and regulatory audits. Prepare documents for records archival. Work in a safe and responsible manner in order to create an injury-free and incident-free workplace. Comply with all job-related safety and other training requirements. Perform other duties as assigned.
BS in related field (Engineering, Industrial Technology, Computer Science, Chemistry, Biology, or other technical or physical/life science) plus two years of relevant experience. Or an AAS in related field with three years of relevant experience. Or four years of relevant experience in related field. Relevant experience includes technical support of computer/equipment/process systems, system testing, laboratory testing, technical and scientific writing, interpretation of regulations/guidelines, review/analysis of data, problem resolution. Familiarity with the pharmaceutical or other regulated industry, proficient in the use of computerized office applications (e.g. Word, Excel, Outlook) and systems/business applications, project management and demonstrated scientific writing skills. Knowledge of cGMPs and FDA/industry expectations.
The Procedure and Contact
DSM's wide diversity of disciplines makes it possible to offer employees a great variety of roles throughout their career. For instance, you may start your career in an area related to your education/qualifications, but your future is what you make of it.
At DSM we stimulate people to determine their own career path and we encourage international careers. We strive to be an Employer of Choice and ensure that our employees are nurtured and given the opportunity to develop their talents.
To learn more about DSM's HR vision and policy, please visit our website at www.dsm.com/careers
We offer a challenging and rewarding job in an innovative multinational company with several opportunities for personal input and development; an open and dynamic atmosphere; a 'never-stop-learning' attitude. Terms and conditions of employment as well as fringe benefits are market competitive.
Please apply online at www.dsm.com/vacancies . The procedure is in line with what you can expect from an Equal Opportunity Employer.
DSM - 21 months ago
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