Company / Establishment
SEQENS is an integrated global leader in pharmaceutical solutions and specialty ingredients, delivering outstanding performance, unrivalled market responsiveness and tailor-made solutions to our customers.
Our mission is to bring R&D and industrial performance to our clients' projects with our unique skill set and a broad range of technologies.
SEQENS operates 24 manufacturing plants and 7 R&D centers in Europe, North America and Asia with 3,200 employees. More than 300 scientists, engineers and experts develop tailor-made solutions for our customers and ensure that products are successfully transferred into production.
Reference
2022-489
Support defining site validation strategy associated with varied site projects covering facilities, utilities, equipment and processes.
• Support defining site validation strategy associated with varied site projects covering facilities, utilities, equipment and processes.
• Develop process validation and equipment qualification requirements (IQ, OQ, PQ)
• Ensure the status of site validation system is established and maintained in accordance with internal procedures, regulatory requirements and industry guidance / standards.
• Lead and/or support risk analysis activities. Demonstrate proficiency in applying various risk management and risk mitigation tools and practices.
• Create/Revise Site validation SOPs.
• Support site change controls and related activities.
• Quality oversight of site validation activities in collaboration with Validation Engineering, and external partners. Review/approve validation protocols/tests/reports.
• Ensure validation and data integrity requirements are met in accordance with company procedures.
• Perform Data Analysis using Statistical methods and Data Analytical Tool.
• Support Equipment life cycle processes.
• Support continuous improvement initiatives and identify and implement tools/processes for continuous improvement.
• Communicate effectively at all levels within Quality, as well as cross functionally with departments and sites.
• Bachelor’s degree in Engineering with a strong knowledge of Quality Engineering /Scientific Method and Techniques.
• 3-5 years experience in Equipment, Facility and Utility IQ/OQ/PQ/PV
• Knowledge in computer System validation in a GMP environment is preferred
• Strong Knowledge of Change Control Practices
• Strong written and verbal communication skills
• Strong Analytical and Statistical skills
• Ability to function efficiently in a diverse, fast paced, and changing environment.
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