Hi,
Hope you are doing great. Kindly find the below requirement and please send me your updated profile to *[email protected]* <[email protected]> *Position*: SR QA Manager / Quality Business System Administration *Duration* : 12 months *Location* : San Francisco, CA Position Reports To: Associate Director, QA IT Systems and Compliance Essential Duties and Responsibilities: ß Maintain system administrative and day-to-day support functions for Quality Enterprise IT systems such as LiveLink EDMS, Pilgrim QMS and ComplianceWire LMS ß Interface with vendors and IT to address and resolve system issues and appropriately communicates gating items to management, Business Process Owners and users ß Lead the development and validation of software implementation projects involving existing or new systems to improve the overall accuracy, efficiency, and effectiveness of the business processes ß Drive the analysis, development, testing, validation and deployment of configuration, workflow, reporting and/or software updates ß Assist in end user training on Quality Enterprise IT systems as needed ß Participates in the continuous improvement and development of Quality Systems to ensure quality and adherence to cGMPs; Supports the development and management of quality metrics to optimize performance, productivity, effective resource planning, and management review Experience: • Minimum 5 years of experience in Quality Assurance • Minimum 2 years of Business System Administration of Quality Enterprise IT software systems • Minimum of 5 years in the pharmaceutical, biotech, diagnostics, medical device or healthcare industry • Knowledge of cGMP and ICH guidelines Skills/ Training/Education: • Required Technical Skills: o Demonstrated knowledge and experience with the administration of Quality Enterprise IT software systems o Working knowledge of relational database management systems such as Oracle and MSSQL o Strong knowledge of applicable Quality Systems and current Good Manufacturing Practice (cGMP) requirements (FDA, EU, ICH) o Strong knowledge of 21 CFR Part 11 and Annex 11 Regulations o Experience in implementing and maintaining GXP computer systems in a validated state with the ability to assess compliance risks • Communication Skills: o Ability to work with internal functional groups to ensure compliance o Ability to represent compliance standards o Excellent verbal communication skills • Other Skills: o Ability to effectively lead projects and manage multiple tasks in meeting deadlines and o Effective time management and interpersonal skills o Strong organizational skills, planning skills and must work effectively within teams o Ability to work with general guidance and multitask o Consistent attention to detail and accuracy o Must have the ability to recognize deviation from accepted practice is required o Strong proficiency in Microsoft Office applications and technical writing • Education Requirements: o 7+ years of relevant experience in a GMP environment related field and a BS or BA o 5+ years of relevant experience and a MS o Degree in Life Sciences or Computer related fields are required deliverables Thanks & Regards, Rita TechnoTalent Software Solutions 707 Alexander Rd. 208, Princeton, NJ 08540 [email protected] 609 - 269 - 2999 Gtalk/Yahoo IM: recruiter.us123 www.technotalent.com E-mail me if I am not reachable over phone. -- You received this message because you are subscribed to the Google Groups "Business_Intelligence" group. To unsubscribe from this group and stop receiving emails from it, send an email to [email protected]. To post to this group, send email to [email protected]. Visit this group at http://groups.google.com/group/business_intelligence. For more options, visit https://groups.google.com/d/optout.
