7-10 years of solid, diverse work experience in a large-scale deployment of QA and Compliance systems at a bio/pharmaceutical company including business process harmonization. Technical expertise is required in global QA and Compliance process design, planning and applying IT solutions to the quality management business function in the pharmaceutical industry. Have full technical knowledge of systems analysis. Technical expertise in applicable industry regulations such as 21 CFR Part 11 for electronic records and electronic signatures; system architecture and design; validation, installation and troubleshooting; business system project management experience; process design; excellent communication skills, analytical ability, strong judgment and management skills. Project management/business analyst skills must include ability to translate business requirements; ability to develop use case scenarios; strong analytical skills (understanding of systems and technical design); ability to assess vendors and software; ability to apply industry trends and metrics; strong understanding of life cycle planning; data modeling skills (ability to map business processes);
gap analysis skills (understanding of cross-functional processes); understanding of business area operations and processes; methodology development; ability to identify and mitigate risks. Thorough understanding of good documentation practices required for GxP compliance. Ability to coordinate cross-functional teams across global operations. Exposure to international quality regulations and compliance issues that pertain to the pharmaceutical industry. Good negotiating and people skills and a good knowledge of global QA and Compliance systems and issues, so as to facilitate timely decision-making. Ability to work effectively with client and I.T. management and staff. Desired skills: Experience with Computer Systems Validation, Systems Development Lifecycle, cGMP requirements and Manufacturing is strongly desired. Bachelor degree in a Physical or Computer Science or chemistry or a related discipline with an advanced degree preferred. Rate Open Celgene Corp/Dendrite in Summit, NJ *Face to face* -- Thanks & regards Sampath Reddy DEREX Technologies Inc. 111 S. Frank E. Rodgers Blvd., Suite # 306, Harrison, NJ 07029 Tel: (973) 486-2402 / Fax: (973) 485-6399 [email protected] / http://www.derextech.com --~--~---------~--~----~------------~-------~--~----~ You received this message because you are subscribed to the Google Groups "Open Source Erp & Crm" group. To post to this group, send email to [email protected] To unsubscribe from this group, send email to [email protected] For more options, visit this group at http://groups.google.com/group/open-source-erp-crm -~----------~----~----~----~------~----~------~--~---
